Call for Abstract

9th World Congress on BA/BE Studies and Biowaivers , will be organized around the theme “Achievements in the field and the integration of new scientific knowledge into regulatory implementation”

Bioequivalence Congress 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Bioequivalence Congress 2017

Submit your abstract to any of the mentioned tracks.

Register now for the conference by choosing an appropriate package suitable to you.

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.

  • Track 1-1Bioequivalence Requirements for Ophthalmic Products
  • Track 1-2Computer-Aided Drug Design
  • Track 1-3Rational Drug Design Approach
  • Track 1-4Novel Approach
  • Track 1-5Carbon nano tubes (CNTS)
  • Track 1-6Topical Drug Development
  • Track 1-7Genetics in Drug Development
  • Track 1-8BA assessment of formulations
  • Track 1-9Phase zero trials
  • Track 1-10Structure based strategies
  • Track 1-11Carbon nano tubes (CNTS)
  • Track 1-12Parallel drug designs

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.

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. 

  • Track 2-1Nutrient Bioavailability
  • Track 2-2Absolute Bioavailability
  • Track 2-3Relative Bioavailability
  • Track 2-4Mineral Bioavailability- Micro and Macro
  • Track 2-5Vitamins Bioavailability
  • Track 2-6BA of Contaminants In Soils & Sediments
  • Track 2-7Drug Absorption and Distribution
  • Track 2-8Disposition studies
  • Track 2-9Product design- Considerations
  • Track 2-10Bio accessibility Factor

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)

  • Track 3-1Metabolite Pharmacological Effects
  • Track 3-2Prodrugs and their active metabolites
  • Track 3-3Metabolic pathway
  • Track 3-4Phase I metabolism of drug: P450 (CYP450)Enzyme
  • Track 3-5Phase I vs. Phase II Metabolism
  • Track 3-6Food/herbal remedies- drug interaction
  • Track 3-7Effects on microsomal enzyme system of the liver
  • Track 3-8Biochemistry applications
  • Track 3-9Plasma Concentrations and Drug Effects
  • Track 3-10Drug Efficacy and toxicity
  • Track 3-11Adverse drug reactions

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. 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.

  • Track 4-1Bioequivalence Protocols : In vitro-In vivo correlation
  • Track 4-2Dissolution Studies
  • Track 4-3Drug-release studies
  • Track 4-4Genetic Phenotyping
  • Track 4-5Response of clinical studies
  • Track 4-6BE of Narrow Therapeutic Index Drugs
  • Track 4-7BE of Endogenous substances
  • Track 4-8BE testing-Geographical considerations
  • Track 4-9Documented standard operating procedures
  • Track 4-10BE-Highly variable drugs and drug products
  • Track 4-11BE -Strategies
  • Track 4-12BE assessment of IR and MR products
  • Track 4-13Alcoholic Beverage Effects on MR Drug Products
  • Track 4-14Analysis of BA/BE by Oral vs Parenteral

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. 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.

  • Track 5-1Pharmacodynamics
  • Track 5-2Drug Interactions
  • Track 5-3Solubility of poorly and high soluble drug
  • Track 5-4Drug Therapy
  • Track 5-5Bio analytical method
  • Track 5-6Clinical Pharmacology
  • Track 5-7Behavioural pharmacology
  • Track 5-8Drug Safety and Efficacy
  • Track 5-9Posology& Development
  • Track 5-10Clinical toxicology
  • Track 5-11Biomarkers
  • Track 5-12Recent Biomedical Innovation

Bioavailability term is defined as a rate & extent of absorption of unaffected drug from its dosage form. 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.

  • Track 6-1Solid Dosage Form
  • Track 6-2Topical Dosage form
  • Track 6-3Parenteral Dosage form
  • Track 6-4Rectal and nasal drug products
  • Track 6-5Solutions and Other Solubilized Dosage Forms
  • Track 6-6Study Design- Single Vs Multiple- Dose
  • Track 6-7In Vitro Dissolution Testing
  • Track 6-8Immediate-Release Products
  • Track 6-9Modified-Release Products
  • Track 6-10Immediate-Release Formulations
  • Track 6-11Modified-Release Formulations
  • Track 6-12Biosensors
  • Track 6-13Bio Analytical Techniques

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)

  • Track 7-1Pre-clinical research/trail
  • Track 7-2Clinical Trial Management
  • Track 7-3Clinical research phase studies
  • Track 7-4In Vitro and In Vivo studies
  • Track 7-5Clinical Study Designs
  • Track 7-6Research and Trials on AIDS / Cancer / Diabetes
  • Track 7-7Bioequivalence Protocol
  • Track 7-8Trial design: formulation development
  • Track 7-9Efficacy and Effectiveness of the trail
  • Track 7-10Role of Biomarkers

Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. 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.

  • Track 8-1Waivers of Pharmaceutical Dosage Form
  • Track 8-2Waivers of Dosage Form Proportionality
  • Track 8-3Waiver for In vivo bioavailability or bioequivalence
  • Track 8-4Biowaiver for SUPAC
  • Track 8-5Waivers of In Vivo Study Requirements
  • Track 8-6Waiver in Dissolutions

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. Biopharmaceutics 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).

  • Track 9-1BCS biowaivers
  • Track 9-2Preclinical and clinical testing for oral drug delivery
  • Track 9-3Consideration of biowaiver extensions for BCS class III drugs
  • Track 9-4In vitro diffusion cells for dissolution testing in formulation development
  • Track 9-5Dissolution testing in drug formulation
  • Track 9-6In vitro preclinical ADME/BCS testing
  • Track 9-7In vitro drug product research
  • Track 9-8Requirement of In Vivo BA or BE Data

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.

  • Track 10-1Biosimilars: Regulatory approach
  • Track 10-2Cancer therapeutics
  • Track 10-3Cardiovascular therapeutics
  • Track 10-4Diabetes therapeutics
  • Track 10-5Commercialization or globalization of biosimilars
  • Track 10-6Plant produced biosimilar products
  • Track 10-7Analytical strategies
  • Track 10-8Adverse drug reactions with pharmaceutical products

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. 

  • Track 11-1Application of drug safety
  • Track 11-2Role of pharma industries
  • Track 11-3Regulatory Affairs
  • Track 11-4Pharmacy Practices and its Challenges
  • Track 11-5Topical and dermatological drug products
  • Track 11-6Physiological factors affecting drug absorption

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 research, clinical 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.

  • Track 12-1Paid Research Studies
  • Track 12-2Paid Clinical Trials
  • Track 12-3GCP Training

Bioequivalence regulations have made stricter, yet there is ample scope of improvement in present bioequivalence study designs. 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.

  • Track 13-1WHO Approaches
  • Track 13-2FDA Approach and regulations
  • Track 13-3TGA and risk management approach
  • Track 13-4Food-Effect Bioavailability and Fed Bioequivalence Studies
  • Track 13-5European Guidelines
  • Track 13-6OTC drug products

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.

  • Track 14-1Novel Drug Delivery Systems- BA/BE approach
  • Track 14-2Role of Nanotechnology in enhancing BA
  • Track 14-3Solid lipid nanoparticle role in study design
  • Track 14-4Bioequivalence Approach for Narrow Therapeutic Index Drugs
  • Track 14-5Comparative drug products (ANDA) bioavailability for generic
  • Track 14-6Generic drugs: Current claims and future directions
  • Track 14-7Pilot study: Design, analysis and Execution
  • Track 14-8Global Nano safety‚ÄĒRegulation vs. innovation
  • Track 14-9BA/BE Studies for Immediate-Release Solid Oral Dosage Forms
  • Track 14-10Generic antibiotic drugs and controversies: TE
  • Track 14-11Food-effect bioavailability and fed bioequivalence studies
  • Track 14-12Scaling approach for BA/BE studies
  • Track 14-13Bioequivalence analysis of highly variable drugs
  • Track 14-14BA Study for cancer drugs
  • Track 14-15Bioavailability - applied studies and advances in methodology
  • Track 14-16Dissolution Specifications for Generic Products

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.

  • Track 16-1BABE study for orally inhaled drug products
  • Track 16-2Bioequivalence Testing For Inhaled Therapeutics
  • Track 16-3Bioequivalence Methodologies for Topical Drug Products
  • Track 16-4BE assessment of transdermal patches