Call for Abstract
9th World Congress on Bioavailability & Bioequivalence, will be organized around the theme “Unfolding Innovations in Bioequivalence/Bioavailability and Related Science”
BABE 2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in BABE 2018
Submit your abstract to any of the mentioned tracks.
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Bioavailability is the measuring of the extent of a therapeutically active medicine that reaches the systemic circulation and is consequently available at the site of action. Bioequivalence is the feature where if two drugs have identical active ingredients contains similar bioavailability and produce the same effect at the place of action.
The measurement of both bioavailability and bioequivalence is crucial to ensure constancy in standards of quality, efficacy &safety of Pharmaceutical dosage forms.
- Track 1-1BA/BE Studies
- Track 1-2Bioequivalence Cardiovascular Products
- Track 1-3Bioequivalence Study Design
- Track 1-4Bioequivalence Study Protocols
- Track 1-5In vitro Bioequivalence
- Track 1-6universal bioavailability
- Track 1-7Bioavailability Metrics
- Track 1-8Waiver of invivo bioavailability
Conducting a Bioavailability study enables assessment of the impact of route of administration on BA and defines the absolute bioavailability 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 play 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
- Track 2-1Factors affecting bioavailability
- Track 2-2Nutrient Bioavailability
- Track 2-3Relative Bioavailability
- Track 2-4Absolute Bioavailability
- Track 2-5Mineral Bioavailability- Micro and Macro
- Track 2-6Vitamins Bioavailability
- Track 2-7BA of Contaminants In Soils & Sediments
Bioequivalence 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 productivity metrics, it’s often said that what gets measured gets done. Bioequivalence is determined based on the 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.
- Track 3-1Bioequivalence Protocols : In vitro-In vivo correlation
- Track 3-2Dissolution Studies
- Track 3-3Drug-release studies
- Track 3-4Genetic Phenotyping
- Track 3-5Response of clinical studies
Designing a new drug is a complex, multi-objective problem, demanding the synchronized optimization 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 4-1Computer-Aided Drug Design
- Track 4-2Rational Drug Design Approach
- Track 4-3Novel Approach
- Track 4-4Genetics in Drug Development
- Track 4-5Topical Drug Development
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.
- Track 5-1Phase I metabolism of drug: P450 (CYP450)Enzyme
- Track 5-2Phase I vs. Phase II Metabolism
- Track 5-3Food/herbal remedies- drug interaction
- Track 5-4Drug Efficacy and toxicity
- Track 5-5Plasma Concentrations and Drug Effects
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, pharmacokinetics, and toxicokinetic 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 6-1Pharmacokinetics
- Track 6-2Pharmacodynamics
- Track 6-3Drug Interactions
- Track 6-4Drug Safety and Efficacy
- Track 6-5Posology& Development
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 every 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.
- Track 7-1Solid Dosage Form
- Track 7-2Topical Dosage form
- Track 7-3Parenteral Dosage form
- Track 7-4Immediate-Release Products
- Track 7-5Modified-Release Products
Clinical trials are the 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 include 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 8-1Pre-clinical research/trail
- Track 8-2Clinical Trial Management
- Track 8-3Clinical research phase studies
- Track 8-4Clinical Study Designs
- Track 8-5Bioequivalence Protocols : In vitro-In vivo correlation
- Track 8-6In Vitro and In Vivo studies
Biowaivers are generally provided for multiple strengths after approval of a bioequivalence study. Biowaiver is applied to a regulatory approval process when the application (dossier) is approved based on evidence of equivalence other than an invivo bioequivalence test. For solid oral dosage forms, the evidence of equivalence is determined based on 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.
- Track 9-1Waivers of In Vivo Study Requirements
- Track 9-2Waivers of Pharmaceutical Dosage Form
- Track 9-3Waiver for In vivo bioavailability or bioequivalence
- Track 9-4Waivers of In Vivo Study Requirements
- Track 9-5Waiver 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 in vivo 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 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 10-1BCS biowaivers
- Track 10-2Preclinical and clinical testing for oral drug delivery
- Track 10-3In vitro preclinical ADME/BCS testing
- Track 10-4In vitro drug product research
- Track 10-5Dissolution testing in drug formulation
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 and focuses on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market
- Track 11-1Cancer therapeutics
- Track 11-2Cardiovascular therapeutics
- Track 11-3Diabetes therapeutics
- Track 11-4Analytical strategies
- Track 11-5Biosimilars: Regulatory approach
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 ,Pharmacovigilance and its Significance and Scope present 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.
- Track 12-1Application of drug safety
- Track 12-2Reporting of ADR
- Track 12-3Pharmacy Practices and its Challenges
- Track 12-4Physiological factors affecting drug absorption
- Track 12-5Regulatory Affairs
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 13-1Design and analysis of BA/BE studies
- Track 13-2Statistical evaluation in BA/BE studies
- Track 13-3Scaling approach for BA/BE studies
- Track 13-4Bioequivalence trials and clinical endpoint studies
- Track 13-5Bioequivalence analysis of highly variable drugs
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 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 14-1WHO Approaches
- Track 14-2FDA Approach and regulations
- Track 14-3TGA and risk management approach
- Track 14-4Food-Effect Bioavailability and Fed Bioequivalence Studies
- Track 14-5European Guidelines
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 enough subjects have completed the study.
- Track 15-1Novel Drug Delivery Systems- BA/BE approach
- Track 15-2Generic drugs: Current claims and future directions
- Track 15-3• BA/BE Studies for Immediate-Release Solid Oral Dosage Forms
- Track 15-4Bioequivalence analysis of highly variable drugs
- Track 15-5Bioavailability Study for cancer drugs
- Track 15-6Food-effect bioavailability and fed bioequivalence studies
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