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Previous Speakers

Kateryna Zupanets

Kateryna Zupanets

National University of Pharmacy Ukraine

Khairia M. Youssef

Khairia M. Youssef

Future University Egypt

Mirko Diksic

Mirko Diksic

McGill University Canada

Sean Zhang

Sean Zhang

Sino-American Pharmaceutical Professionals Association USA

Sinerik Ayrapetyan

Sinerik Ayrapetyan

UNESCO Armenia

Wolfgang Sadee

Wolfgang Sadee

The Ohio State University USA

Akwete Lex Adjei

Akwete Lex Adjei

Rhodes Pharmaceuticals L.P USA

Jim Jingjun Huang

Jim Jingjun Huang

Ascendia Pharmaceuticals USA

BABE 2018

Scientific Sessions/ Tracks

Track 1: Drug Design and development: Challenges

Designing a new drug is a complex, multi-objective problem, demanding the synchronized optimisation of target affinity, tissue exposure, formulation, toxicity and so on. Novel drug designers are constantly identifying innovative methods that can be used to improve their drug design. The challenge met nowadays is, how to integrate these multiple inputs and opinions to increase their effect and accelerate drug discovery projects into the clinical outcomes, patient safety for the effective and sustained use of medicines.

Topics under this track includes Computer-Aided Drug Design, Rational Drug Design Approach, Novel Approach, Physiological Drug Environment, Topical Drug Development, Genetics in Drug Development, BA assessment of formulations

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2nd International Conference and Exhibition on Pharmaceutical Development and Technology May 14-15, 2018 Tokyo, Japan  20th International Conference on Pharmacy and Pharmaceutical Sciences  London, United Kingdom February 15 - 16, 2018  IIIrd International Conference on Researches in Science & Technology 20-21 Feb 2018, Dubai Global Pharmacovigilance 2018, July 09-10, 2018 Sydney, Australia 5th Asia-Pacific Pharma Congress July 16-18, 2018 Melbourne, Australia 2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 2: BA Studies and Assessment

Conducting a BA study enables assessment of the impact of route of administration on BA and defines the absolute BA of the drug released from the drug product. BA for a given formulation provides an assessment of the relative fraction of the orally administered dose that is absorbed into the systemic circulation. If the reference standard is an IV dose, it is referred as Absolute Bioavailability. If the reference standard is any other dosage form than IV it is referred as Relative Bioavailability. Micro and Micro nutrients plays a vital role in bioavailability.

Bioavailability is a subcategory of pharmacological absorption. Bioavailability is generally assessed by finding the area under the plasma concentration–time curve. The factors affecting bioavailability are Pharmaceutics factors, physicochemical properties of drug, Dosage form characteristics & Pharmaceutic Ingredients, Patient related factors like age, Routes of administration (Parenteral, Rectal, Oral, and Topical)  etc. Topics under this track includes Nutrient Bioavailability, Absolute Bioavailability, Relative Bioavailability, Mineral Bioavailability- Micro and Macro, Vitamins Bioavailability, BA of Contaminants In Soils & Sediments, Drug Absorption and Distribution, Disposition studies , Drug Formulation and Dosage Forms, Product design- Considerations, Bio accessibility Factor

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2th Annual Pharma Middle East Congress Sep 25-26, 2017 Dubai, UAE  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  16th Annual Medicinal & Pharmaceutical Sciences Congress October 16-17, 2017 Seoul, South Korea   9th Annual Congress on Drug Design & Drug Formulation October 19-20, 2017 Seoul, South Korea 2nd international summit on pharma & clinical trails June 11-12,2018. Paris,France  International collonium on Medical,Pharma & Drug Studies November 29-30,2017 Brisbane ,Australia 

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 3: Drug Metabolism

Drug metabolism is the term used to describe the biotransformation of pharmaceutical substances in the body so that they can be eliminated more easily. The metabolites of some drugs are pharmacologically active and exert an effect on the body. The active metabolite of some medications is responsible for the principal action of the drug. In this case, the drug formulation is referred to as a prodrug (some chemical substances which do not produce pharmacological effects until they are chemically altered within the body). The rate of drug metabolism affects the efficacy and toxicity of the drug for patients who have very high or low metabolism rates.

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

12th Global Pharmacovigilance & Clinical Trials Summit July 09-10, 2018 Sydney, Australia 11th International Conference on Pharmacoepidemiology and Clinical Research October 02-04, 2017 Kuala Lumpur, Malaysia  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 4: BE Studies and Assessment

BE studies are done for Early and late clinical trial formulations, Formulations used in clinical trial and stability studies,  if different Clinical trial formulations and to-be-marketed drug product When it comes to  cost and productivitymetrics, it’s often said that what gets measured gets done. Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. A typical outline for a bioequivalence study includes organization of the test and reference items on two events to volunteer subjects, with every organization isolated by a washout period. This Study involves parameters on (Cmax) and (AUC), Statistical evaluation.

Assessment of the bioequivalence of generic versions of certain reference drugs is complicated by the presence of endogenous levels of said compounds which cannot be distinguished from externally derived compound levels following drug administration. If unaccounted for, the presence of endogenous compound biases towards equivalence in bioequivalence studies of these drugs. Bioequivalence assessments may be complicated further as disposition of the exogenous analogue can be subject to various endogenous processes resulting in nonlinear pharmacokinetics. To overcome these inherent biases a number of different strategies have been employed.

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2nd International Conference and Exhibition on Pharmaceutical Development and Technology May 14-15, 2018 Tokyo, Japan  20th International Conference on Pharmacy and Pharmaceutical Sciences  London, United Kingdom February 15 - 16, 2018  IIIrd International Conference on Researches in Science & Technology 20-21 Feb 2018, Dubai Global Pharmacovigilance 2018, July 09-10, 2018 Sydney, Australia 5th Asia-Pacific Pharma Congress July 16-18, 2018 Melbourne, Australia 2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 5: Pharmacology- PK & PD approach

Pharmacodynamics and pharmacokinetics are the two principal areas of pharmacology. Pharmacodynamics is the study of the molecular, biochemical, and physiological effects of drugs on cellular systems and their mechanisms of action. Pharmacokinetics focuses rather on how the body affects the drug, in terms of its absorption, metabolism, distribution and elimination. Today, pharmacologists use a variety of techniques, including genetics, molecular biology and chemistry, to explain and manipulate the pharmacological action of substances for health purposes. BA and BE frequently rely on pharmacokinetic measures such AUC to assess extent of systemic exposure and Cmax and Tmax to assess rate of systemic absorption.

It has a broad scope, from the discovery of new target molecules, to the effects of drug usage in whole populations. Clinical pharmacologists work in a variety of settings in academia, industry and government. In the laboratory setting they study biomarkers, pharmacokinetics, drug metabolism and genetics. Bioanalytical method techniques and validation plays a vital role in the evaluation and interpretation of bioequivalence, PK, and toxic kinetic studies. Clinical and experimental pharmacology deals with Clinical drug developments & therapeutics. Pharmacogenomics is the study of how genetic variation influences responses to drugs. This includes how genetic variants affect drug metabolism, efficacy and toxicity, with the goal of improving and personalizing drug therapy.

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2th Annual Pharma Middle East Congress Sep 25-26, 2017 Dubai, UAE  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  16th Annual Medicinal & Pharmaceutical Sciences Congress October 16-17, 2017 Seoul, South Korea   9th Annual Congress on Drug Design & Drug Formulation October 19-20, 2017 Seoul, South Korea 2nd international summit on pharma & clinical trails June 11-12,2018. Paris,France  International collonium on Medical,Pharma & Drug Studies November 29-30,2017 Brisbane ,Australia 

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 6: Pharmaceutical Dosage Forms

The general area of study related with the physical, chemical and biological factors influencing the formulation, manufacturing, stability and effectiveness of pharmaceutical dosage forms is called as pharmaceutics. There are different forms into which a drug may be for convenient and effective treatment of disease. Drugs can be prepared for administration by very conceivable route and the suitable preparation is formulated to insure maximum therapeutic response. These may be tablets, capsules, solutions, syrups, elixirs, suspensions, gels, powders, troches or lozenge, ointments, creams, pastes, aerosol, lotions, sprays, inhalants, emulsions and suppositories. 

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

12th Global Pharmacovigilance & Clinical Trials Summit July 09-10, 2018 Sydney, Australia 11th International Conference on Pharmacoepidemiology and Clinical Research October 02-04, 2017 Kuala Lumpur, Malaysia  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 7: Clinical Research Vs Clinical Trails

Clinical trials are nothing but experiments done in clinical research. Clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. Each clinical trial has a plan of action or a protocol for conducting trial. Clinical trials generate data on safety and efficacy. Different types of clinical research includes Treatment, Prevention, Diagnostic, Screening, Quality of life, Genetic studies, Epidemiological studies, Phases of clinical trials (when clinical research is used to evaluate medications and devices)

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2nd International Conference and Exhibition on Pharmaceutical Development and Technology May 14-15, 2018 Tokyo, Japan  20th International Conference on Pharmacy and Pharmaceutical Sciences  London, United Kingdom February 15 - 16, 2018  IIIrd International Conference on Researches in Science & Technology 20-21 Feb 2018, Dubai Global Pharmacovigilance 2018, July 09-10, 2018 Sydney, Australia 5th Asia-Pacific Pharma Congress July 16-18, 2018 Melbourne, Australia 2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 8: Biowaivers: Criteria

Biowaivers are generally provided for multiple strengths after approval of a bioequivalence study. Bio waiver is applied to a regulatory approval process when the application (dossier) is approved on the basis of evidence of equivalence other than an in vivo BE test. For solid oral dosage forms, the evidence of equivalence is determined on the basis of an invitro dissolution profile comparison between the multisource and the comparator product. The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

12th Global Pharmacovigilance & Clinical Trials Summit July 09-10, 2018 Sydney, Australia 11th International Conference on Pharmacoepidemiology and Clinical Research October 02-04, 2017 Kuala Lumpur, Malaysia  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 9: BCS & IVIVC Based Biowaivers

The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugsBiopharmaceutics Classification System and invitro and invivo classification discusses about ADME pathways of different drugs. This also includes BCS biowaivers, In vitro diffusion cells for dissolution testing in formulation development, In vitro preclinical ADME/BCS testing. Until in vitro in vivo correlation achieves the required degree, the biosimilar drug will not be able to meet the needs of the original drug candidate. The proportion of BCS and IVIVC based biowaivers are fairly low for pharmaceutical products. This classification can be used as a basis for setting in vitro dissolution specifications and can also provide a basis for predicting the likelihood of achieving a successful in vivo-in vitro correlation (IVIVC).

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2nd International Conference and Exhibition on Pharmaceutical Development and Technology May 14-15, 2018 Tokyo, Japan  20th International Conference on Pharmacy and Pharmaceutical Sciences  London, United Kingdom February 15 - 16, 2018  IIIrd International Conference on Researches in Science & Technology 20-21 Feb 2018, Dubai Global Pharmacovigilance 2018, July 09-10, 2018 Sydney, Australia 5th Asia-Pacific Pharma Congress July 16-18, 2018 Melbourne, Australia 2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 10: Recent approaches to Biosimilars

The development of biologics calls for overcoming lot many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labelling requirements. Also it is much required now to develop a drug product in accordance to quality by design (QbD). This Bioequivalence conference will look at the multiple facets of current challenges in biosimilar development. This conference will focus on multiple aspects of bio similar product development to successfully deliver safe, potential and efficacious biologic products to the market.

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2th Annual Pharma Middle East Congress Sep 25-26, 2017 Dubai, UAE  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  16th Annual Medicinal & Pharmaceutical Sciences Congress October 16-17, 2017 Seoul, South Korea   9th Annual Congress on Drug Design & Drug Formulation October 19-20, 2017 Seoul, South Korea 2nd international summit on pharma & clinical trails June 11-12,2018. Paris,France  International collonium on Medical,Pharma & Drug Studies November 29-30,2017 Brisbane ,Australia 

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 11: Drug Safety: Pharmaocovigilance Scope

Drug Safety is the pharmacological science ensuring safety and related to the collection, detection, assessment, monitoring, and prevention of adverse side effects with pharmacological action of pharmaceutical products. According to US FDA a drug is regarded as safe by looking at side effects, its manufacturing process and results of animal testing and clinical trials. In this track, we discuss Drug safety and its applications in various fields such as Softwares, Training etc. Pharmacovigilance and its Significance and Scope present the case for the importance of pharmacovigilance, to record its growth and potential as an important discipline within Medical science, and to describe its impact on patient welfare and public health and to know what is pharmacovigilance. In this track, we discussion includes on Significance of pharmacovigilance, role in healthcare system.

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12th Global Pharmacovigilance & Clinical Trials Summit July 09-10, 2018 Sydney, Australia 11th International Conference on Pharmacoepidemiology and Clinical Research October 02-04, 2017 Kuala Lumpur, Malaysia  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 12: Contract Research Organizations

A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical researchclinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to governmental organizations. Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2th Annual Pharma Middle East Congress Sep 25-26, 2017 Dubai, UAE  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  16th Annual Medicinal & Pharmaceutical Sciences Congress October 16-17, 2017 Seoul, South Korea   9th Annual Congress on Drug Design & Drug Formulation October 19-20, 2017 Seoul, South Korea 2nd international summit on pharma & clinical trails June 11-12,2018. Paris,France  International collonium on Medical,Pharma & Drug Studies November 29-30,2017 Brisbane ,Australia 

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 13: Regulatory Requirements and Approaches

Bioequivalence regulations have made stricter, yet there is ample scope of improvement in present bioequivalence study designs. Areas where amendments are desired include: general study design, blinding, gender of subject, female subjects, body mass index, and replacement of subjects on withdrawal or, dropouts, genetic phenotyping, endogenous substances, emesis / vomiting and washout period, respectively. Bioavailability and Bioequivalence studies are conducted in healthy human volunteer in study centre. Study centres requires Clinical Pharmacology Unit (CPU) and Bio analytical laboratory. The design and conduct of comparative bioavailability studies are formulated. Investigator(s) should have appropriate expertise, qualifications and competence to undertake a proposed study and is familiar with pharmacokinetic theories underlying bioavailability studies. The design should be based on a reasonable knowledge of the pharmacodynamics and/or the pharmacokinetics of the active substance in question. BA/BE studies are needed by regulations to guarantee remedial proportionality between a pharmaceutically comparable test item and a reference item. BA/BE studies are finished Early and late clinical trial definitions, Formulations utilized as a part of clinical trial and steadiness studies.

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

2nd International Conference and Exhibition on Pharmaceutical Development and Technology May 14-15, 2018 Tokyo, Japan  20th International Conference on Pharmacy and Pharmaceutical Sciences  London, United Kingdom February 15 - 16, 2018  IIIrd International Conference on Researches in Science & Technology 20-21 Feb 2018, Dubai Global Pharmacovigilance 2018, July 09-10, 2018 Sydney, Australia 5th Asia-Pacific Pharma Congress July 16-18, 2018 Melbourne, Australia 2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands 

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 14: Recent advancements in BA/BE Research

The aim of bioavailability study is to find out the dosage form influence on the biological performance of the drug, sensitivity to detect differences in the rate and extent of absorption. Bioavailability and bioequivalence study design involves Single dose or multi dose standard 2x 2 crossovers, Parallel groups, for more than two formulations. A study design meant for estimating essential pharmacokinetic parameters differs significantly from a bioequivalence study meant for comparing the test formulation. The results of a pilot study can be used as the sole basis to document BA or BE provided the study’s design and execution are suitable and a sufficient number of subjects have completed the study.

Related Pharma drug research Conferences | pharmaceutical drug research and development | Dissolution Events

12th Global Pharmacovigilance & Clinical Trials Summit July 09-10, 2018 Sydney, Australia 11th International Conference on Pharmacoepidemiology and Clinical Research October 02-04, 2017 Kuala Lumpur, Malaysia  4th International  Biomedical Engineering Conference October 16-17, 2017 Osaka, Japan  2nd International Conference and Exhibition on Nanomedicine and Drug Delivery May 14-16, 2018 Tokyo, Japan 14th International Conference and Exhibition on Nanomedicine and Pharmaceutical Nanotechnology April 09-11, 2018 Amsterdam, Netherlands

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

Track 15: Pharmaceutical Industry: Entrepreneurs Investment Meet

A platform aimed to connect Entrepreneurs, Proposers and the Investors worldwide. It's intended to create and facilitate the most optimized and viable meeting place for engaging people in global business discussions, evaluation and execution of promising business ideas. An investor could be able to find out the highest potential investment opportunities globally, which provide good return on investment. For entrepreneurs, this would be an ideal place to find out suitable investors and partners to start and/or expand their business. Thus it is a perfect place to connect Entrepreneurs, Business Owners, Early Stage Companies and Established Corporates with National or International Investors, Corporate Investors and Potential Business Partners.

Related Associations or Societies:

Generic Pharmaceutical Association | US Food and Drug Administration( FDA) | European Generic medicines Association | Therapeutics Goods Administration (TGA) | European Economic Area | Canadian Generic Pharmaceutical Association (CGPA) | Bioequivalence and Bioavailability forum  |  FDA Office of Surveillance and Epidemiology  | American Association for Clinical Chemistry (AACC) | American Association of Pharmaceutical Scientists (AAPS) | Clinical Trials Information from National Institutes for Health (NIH) | National Institute of Standards and Technology (NIST)

About Conference


Conference Series Ltd organizes a conference series of 1000+ Global Events inclusive of 1000+ Conferences, 500+ Upcoming and Previous Symposiums and Workshops in USA, Europe & Asia with support from 1000 more scientific societies and publishes 700+ Open access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Conference Series Ltd is an outstanding organization that organizes highly notable global roundup of Pharmaceutical Conferences . It’s glad to oraganize 9th World Congress on Bioavailability and Bioequivalence” (BABE 2018) in UAE on March 19-21, 2018 at Dubai after a similar series of conferences in consecutive years at USA over the last several years which met with great achievement in Business Conferencing.

This unique international conference will opportunity to reach the largest assemblage of participants from the Pharmaceutical community to gather and share their insights and convey recent developments in the field of generic drug research and current challenges and possibilities in modelling a new drug and breakthroughs in drug development, Generic drug safety, Novel trends and advanced strategies involving bioavailability bioequivalence research. This is a true forum where ideas and discussion is driven by the participants and interaction with peers and others leads to fruitful outcomes.

BABE 2018 is a 3-day event offering the Exhibition, at venue to showcase the new and emerging technologies and have wider sessions involving  Keynote presentationOralYRF ( student presentation), postere-poster presentations. World-renowned speakers and eminent delegates across the globe attending the conference, to share their valuable presentation on the most recent and advanced techniques, developments, and the newest updates are the prominent features of the conference.

Who to attend:

  • CEOs, CROs, Directors, Managers and research associates in pharmaceutical industry in the drug or device industries (both innovator and generic)
  • Academic and Industrial Scientists Associated with Discovery, Formulation and The Delivery of Drugs
  • Regulatory and Clinical Scientists Involved In Drug Development
  • Researchers, Education providers In Clinical Pharmacy, Pharmacology and Toxicology
  • Students and Postdoctoral Fellows In All Areas of The Pharmaceutical Sciences
  • Government Agencies Involved In Chemical Safety Assessment
  • Medical Practitioners Such As Clinical Pharmacologists, Clinical Toxicologists.
  • Molecular and Cellular Pharmacologists

Why to attend??

  • Exchange ideas and network with leading pharmaceutical scientists and clinicians and presenting cutting-edge discoveries, research and new therapeutic drugs
  • Obtain a global roundup of Pharmaceutical research capabilities and opportunities

Market Analysis

 

Market Analysis of  Pharmaceutical Industry in emerging Genric drugs:

The global generic drugs market 2016 report forecasts patent expiry of drugs worth $150 billion by 2020, which a key growth driver for top-selling drugs as well as new, inexpensive generic drugs. With many pharmaceutical drugs set to lose their patents during the forecast period, the competition in the generic market is expected to increase. Patent expiry of a branded drug results in the introduction of inexpensive generic drugs in the market. Branded drugs with sales of up to $135 billion expired by the end of 2015, offering pharmaceutical companies opportunities to capitalize on this market.

 

The analysts forecast global generic drugs market to expand at a compound annual growth rate (CAGR) of 10.53% during the period 2016-2020. One trend which is influencing generic drugs market growth is the outsourcing of drug development. Some vendors outsource parts of their R&D process, such as product characterization testing, and toxicology testing, to contract research organizations. Similarly, some of them outsource parts or even the entirety of their manufacturing processes to other organizations. In this way, outsourcing is becoming a trend in the global generic drugs market.

Major Pharmaceutical Associations around the Globe

  • Bioanalytical Focus Group and Ligand Binding Assay
  • American Association of Pharmaceutical Scientists (AAPS)
  • Royal Netherlands Chemical Society
  • The European Bioanalysis Forum
  • BEBAC Consultancy Services for Bioequivalence and Bioavailability
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • European Generics and Biosimilar Medicines Association (EGA)
  • Canadian Generic Pharmaceutical Association (CGPA)
  • Bioequivalence and Bioavailability forum
  • Generic Pharmaceutical Association (GPhA)
  • Pharmaceutical Management Agency (PHARMAC)
  • FDA Office of Surveillance and Epidemiology
  • Drug Watch
  • ORPHANET Parenteral Drug Association
  • PharmGKB
  • US Food and Drug Administration (FDA)
  • American Association for Clinical Chemistry (AACC)
  • American Association of Pharmaceutical Scientists (AAPS)
  • Clinical Trials Information from National Institutes for Health (NIH)
  • National Institute of Standards and Technology (NIST)
  • Association of the British Pharmaceutical Industry (ABPI)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Innovative Medicines Canada

 

Past Conference Report

BABE 2016

Our Cordial thanks to all of our wondrous and famed speakers, conference attendees, students, associations and guests for shaping BABE 2016 an ineradicable event and a mile stone.

Conference Series LLC hosted the 7th World Congress on Bioavailability and Bioequivalence: BA/BE Studies Summit during August 29-31, 2016 at Atlanta, USA. The conference was designed around the theme of “Amalgamation of traditional techniques to advanced studies which redefine BA/BE approach and perception” and was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering. Moreover, the networking sessions laid the foundation for some time worthy collaborations between many start-up and big industries. The post conference networking lunch session witnessed a number of B2B meetings that are turning up to be mutually beneficial to both the organizations who had gone in for the business meetings.

BABE 2016 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Bioavailability and Bioequivalence. This congress not only brought forward the latest developments in the field but also provided solutions to the numerous challenges encountered in generic drug sector.

Conference Series LLC would like to convey a warm gratitude to all the Honourable guests, Keynote Speakers, Delegates, Media Partners and Exhibitors for their participation in BABE 2016. The conference was initiated with a series of lectures delivered by both Honorable Guests and members of the Keynote forum. The list includes:

·         Jim Jingjun Huang, Ascendia Pharmaceuticals, USA      

·         Mewa Singh, Meda Biotech LLC, USA

·         Akwete Lex Adjei, Rhodes Pharmaceuticals L.P, USA

 
We on behalf of the conference specially thank Kateryna Zupanets for her support as a moderator for the conference. We also thank Sue Duran, Auburn University, USA and Muneesh Garg, Sitec Labs, India for their support for success of the conference. Conference Series LLC also took the privilege of felicitating BABE 2016 Organizing Committee, Keynote Speakers, and Chair and Co-Chairs whose support made conference a great success with various sessions and multiple presentations.

With the enormous feedback from the participants and supporters of BABE 2016, we are glad to announce 9th World Congress on BA/BE Studies and Biowaivers during July 17-19, 2017 at Melbourne, Australia.

 

For More details visit: http://bioavailability-bioequivalence.pharmaceuticalconferences.com/asiapacific/

 


Past Reports  Proceedings  Gallery   

BABE-2015
 

We would like to thank all of our wonderful speakers, conference attendees, students, associations and guests for making BABE-2015 a wonderful event!

BABE-2015 which was scheduled during August 17-19, 2015 at Chicago, USA with the theme “Advance Approaches in Discussion of Current Issues & Future Possibilities in Bioavailability and Bioequivalence Studies”. The conference had several workshops, multiple sessions, Keynote presentations, panel discussions and Poster sessions. We received active participation from various leaders from the fields  of Bioavailability and Bioequivalence Research Centres, Professors, Companies, Researchers, students and Research Professionals, who made this event a Grand Success.

Various sessions were carried out with multiple presentations from speakers all around the world. Major Sessions to be discussed were:

·         Emerging Bioavailability and Bioequivalence Studies

·         Bioanalytival Methodology

·         Contempory challenges of drugdesign ,discovery and development

·         Regulatory policies procedures prerequisites for clinical research

·         Managing BA/BE studies

·         Relevance of Genetics to BA/BE in Drug Development

·         Bioavailability, Bioequivalence and Drug Product Selection

·         Advances in Assessment of Bioequivalence

·         Need for conducting  BA/BE studies

·         Metabolic Pathways and Changes in Nutrient Bioavailability

·         Clinical Pharmacology and Therapeutics

·         Study Designs

·         Factors Affecting Bioavailability

The conference was initiated with a series of lectures delivered by both Honorable Guests and members of the Keynote forum. The list includes:

  • Paramjeet Kaur, U.S. Food and Drug Administration, USA
  • Jim Jingjun Huang, Ascendia Pharmaceuticals, USA
  • Keith Gallicano, Novum Pharmaceutical Research Services, USA

Series of workshops includes expert presentation by Paramjeet Kaur, U.S. Food and Drug Administration, USA, on “Biowaiver approaches for generic drug products in the US: case studies”, Jim Jingjun Huang, Ascendia Pharmaceuticals, USA on “Rational design of amorphous solid dispersion for solubility and bioavailability enhancement”, Keith Gallicano, Novum Pharmaceutical Research Services, USA on “Bioequivalence of topical corticosteroids: Design and data analysis challenges with the vasoconstrictor assay”. We specially thank Murat Sari, Pharmactive, Turkey, for his support as a moderator for the conference. We also thank Subrata Deb, Roosevelt University College of Pharmacy, USA for his support for success of the conference.

OMICS International offers its heartfelt appreciation to the Organizing Committee Members, namely Harish Pant, G. Ali Mansoori, A. M. Abd El-Aty, Sachin S Devi who supported us throughout the event. Also, it would be incomplete without thanking all our expert presenters from all around the world which includes various outside experts, company representatives and other eminent personalities who supported the conference by facilitating the discussion forums.

With the grand success of BABE-2015, OMICS International is proud to announce the “7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit " to be held during August 29-31, 2016 at Atlanta, USA.

For More details visit: http://bioavailability-bioequivalence.pharmaceuticalconferences.com/

To Collaborate Scientific Professionals around the World

Conference Date March 19-21, 2018

For Sponsors & Exhibitors

[email protected]

Speaker Opportunity

Past Conference Report

Supported By

Journal of Bioequivalence & Bioavailability Journal of Bioanalysis & Biomedicine Pharmaceutica Analytica Acta

All accepted abstracts will be published in respective Conferenceseries International Journals.

Abstracts will be provided with Digital Object Identifier by


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