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.

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

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

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 2-2Relative Bioavailability
  • Track 2-3Absolute Bioavailability
  • Track 2-4Mineral Bioavailability- Micro and Macro
  • Track 2-5Vitamins Bioavailability
  • Track 2-6BA of Contaminants In Soils & Sediments

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 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 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 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

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 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. 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 6-1Pharmacokinetics
  • Track 6-2Pharmacodynamics
  • Track 6-3Drug Interactions
  • Track 6-4Drug Safety and Efficacy
  • Track 6-5Posology& Development

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 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 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 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 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.

  • 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 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 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. 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 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 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 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. 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 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 a sufficient number of 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
  • Track 16-1BA/BE Perspectives for Drug Products
  • Track 16-2BABE study for orally inhaled drug products
  • Track 16-3Bioequivalence Testing For Inhaled Therapeutics
  • Track 16-4Bioequivalence Methodologies for Topical Drug Products

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