Call for Abstract

8th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit , will be organized around the theme “Throwing Light on Latest Techniques for Optimization of Drug Solubility, Delivery and Stability for Maximization of Product Life Cycles”

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

Submit your abstract to any of the mentioned tracks. All related abstracts are accepted.

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

In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behaviour, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. Preclinical trials are early experiments performed in the lab, prior to being tested in humans. This early research helps to identify potential treatments that are unsafe or ineffective. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).

The market of clinical trials in India is predicted to reach at a CAGR of nearly 36% between 2006–2011 to gain revenues worth US $ 546 Million in future. The Prime advantage of conducting clinical trials in India is the availability of a huge patient pool that can be initiated at much lower time then it takes to recruit patients in the west.

  • Track 1-1Pre-clinical Studies
  • Track 1-2Clinical Trials USA
  • Track 1-3Clinical Trial Companies
  • Track 1-4Clinical Trial Services
  • Track 1-5Clinical Trial Management
  • Track 1-6Pediatric Clinical Trials

Clinical trials are used to evaluate potential treatments that have had some effect against disease in the lab, or in animal experiments. The whole point of a clinical trial is to find out if a treatment is effective. The aim of clinical trials is to determine if a treatment works and is safe. By comparing similar groups of people taking different treatments for the same disease it is possible to show whether any benefits are due to the treatment. Effective treatments identified in this way may then become standard practice. Since the research is experimental, those who take part in early studies may not always benefit. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice. Standard practice is a currently accepted and widely used approach and would require approval by a government body such as the FDA or EMEA.

The market of clinical trials in India is predicted to reach at a CAGR of nearly 36% between 2006–2011 to gain revenues worth US $ 546 Million in future. The Prime advantage of conducting clinical trials in India is the availability of a huge patient pool that can be initiated at much lower time then it takes to recruit patients in the west.

  • Track 2-1Cancer Clinical Trial
  • Track 2-2Diabetic Clinical Trials
  • Track 2-3Anti Viral Clinical Trials
  • Track 2-4Other Pharmaceutical Clinical Trials

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.

The global contract research organizations services market is assessment to grow at a CAGR of 7.4% from 2016 to 2021 to reach USD 41.86 Billion by 2021. Growing R&D expenditure, increased redistribute of R&D activities, growing demand for redistribute  analytical testing and clinical trial services, and development in the number of clinical trials are habitual to propel the growth of this market. However, developing regulatory pressure on CROs can hinder their market growth to a positive extent.

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

Any drug that is taken undergoes a number of chemical reactions in the liver as the body attempts to neutralize foreign substances.  This set of reactions is well characterized, and a great deal of knowledge exists as to how drugs are modified as the body eliminates them.  More importantly, various chemical structures are highly toxic to biological systems, and these are also well characterized.  These constraints must also be taken under consideration as novel drugs are developed. The annual decline in the number of drugs approved for release onto the market in recent years has put pressure on you and your team to refine the drug discovery process and use more effective methods to discover a higher number of successful lead compounds.

Drug Design is an extraordinary inventive process of new medication on the basis of biological target. Drug Discovery Informatics Market size was USD 1.6 billion in 2015 and is forecast to reach around USD 6.5 billion by 2023. In 2012 total market for Drug Discovery Informatics was around in between 400 to 500 million, and is familiar to reach around more than 3,500 million in 2022.

  • Track 4-1Structure based strategies
  • Track 4-2Carbon nano tubes (CNTS)
  • Track 4-3parallel drug designs

Considerable challenges in drug development, particularly in the face of further organizational changes slated for OGD. A range of legislative and regulatory actions have facilitated consumer access to safe, high-quality generic products, although manufacturing lapses and product quality problems have created critical shortages in important medicines, casting a shadow over the industry's success.

In 2012 the global market for drug development and services reached $3.5 billion. This market is reached $4.5 billion in 2013 and expected to reach 11.7 billion in 2018, a compound annual growth rate (CAGR) of 21.2%.

  • Track 5-1Phase zero trials
  • Track 5-2Mechanism

Amount of a substance that becomes available (reaches the target organ or systemic circulation) to an organism's body for bioactivity when introduced through ingestion, inhalation, injection, or skin contact. Rate of bioavailability depends on factors such as the type of the substance and the composition of diet.

By analyzing global market trends with data from 2012 and 2013 projections of compound annual growth rates (CAGRs) through 2018.The North American market is expected to reach around $79 billion in 2017 and is expected to raise at a 7.9% compound annual growth rate to nearly $108 billion in 2020.

  • Track 6-1Liquisolid technology
  • Track 6-2Prodrugs
  • Track 6-3Oral drugs
  • Track 6-4Therapeutic systems
  • Track 6-5Food effect

If two medicines are bioequivalent there is no clinically significant difference in their bioavailability. Although bioequivalence is most commonly discussed in relation to generic medicines, it is important to note that bioequivalence studies are also performed for innovator medicines in some situations such as: between early and late clinical trial formulations or between the formulations used in clinical trials and the product to be marketed for new medicines when changes in formulation have occurred after an innovator product has been approved, for example a change in one or more excipients (inactive ingredients)

  • Track 7-1Pharmacokinetic Studies
  • Track 7-2Pharmacodynamic Studies
  • Track 7-3Clinical Studies
  • Track 7-4IVIVC
  • Track 7-5Earlier exposure on BE

This section provides recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance herein explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme. Data on bioequivalence provide a bridge between two or more pharmaceutical equivalents when safety and efficacy data are available for one of the products, but not for the other. For multisource products bioequivalence studies/bioequivalence assessment conferences are necessary to ensure therapeutic equivalence and interchange ability of the products. Bioequivalence can also be demonstrated by comparative clinical studies, pharmacokinetic studies or appropriate in vitro studies.

  • Track 8-1Analysis of BA/BE by oral vs parentral
  • Track 8-2Criterion for bioequivalence confidence interval approach
  • Track 8-3Parametric vs non-parametric tests
  • Track 8-4Bioequivalence of endogenous substances
  • Track 8-5Plasma concentration vs time curve (AUC) based dosing
  • Track 8-6Adverse drug reactions
  • Track 8-7In narrow therapeutic index drugs

In pharmacology, bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs.  There are many recent advances and factors affecting Bioavailability. It includes Absorption, metabolism and Food effect of Drugs. Physico-chemical factors, first pass metabolism and Energy dependent efflux transporters are also discussed in BA/BE World Congress.

  • Track 9-1Absorption
  • Track 9-2Food Effect
  • Track 9-3Drug metabolism/ biotransformation
  • Track 9-4Energy dependent efflux transporters
  • Track 9-5Physico-chemical factors
  • Track 9-6First pass metabolism
  • Track 9-7CYP450 isozymes

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 10-1Solubility based on highest dose strength of an IR product
  • Track 10-2Establishment of bioequivalence criteria
  • Track 10-3Drugs possessing narrow therapeutic index
  • Track 10-4Waivers of In Vivo Study Requirements
  • Track 10-5Biopharmaceutics Classification System (BCS)
  • Track 10-6Topical dosage forms
  • Track 10-7Respiratory dosage forms
  • Track 10-8Transdermal dosage forms
  • Track 10-9Evaluation of highly variable drugs and drug products

It includes randomized, two-period, two-sequence, single dose cross-over design, parallel design and replicate designs. Absolute and Relative bioavailability are discussed. Pharmacokinetics and Pharmacodynamics of the study designs make an important role.

  • Track 11-1Bioequivalence Study Design
  • Track 11-2Bioavailability Study design
  • Track 11-3Randomized, two-period, two-sequence, single dose cross-over design, parallel design and replicate designs
  • Track 11-4Absolute bioavailability
  • Track 11-5Relative bioavailability
  • Track 11-6Pharmacokinetics & pharmacodynamics

Both bioavailability and bioequivalence focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation. Bioavailability and Bioequivalence studies are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. Several in vivo and in vitro methods are used to measure product quality.

  • Track 12-1Drug formulations
  • Track 12-2Fixed-dose combination products
  • Track 12-3Manufacturing drugs

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. Everybody has more heaped on their plate than any time in recent remembrance, and numerous consultant discover themselves always re-organizing their work exercises.

BA/BE studies and conferences are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. 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. Part of this is human nature. Everyone has more piled on their plate than ever, and many workers find themselves constantly re-prioritizing their work activities

  • Track 13-1Cost, quality and productivity metrics
  • Track 13-2Geographical considerations in bioequivalence testing
  • Track 13-3Adverse events
  • Track 13-4Documented standard operating procedures

Clinical research means an investigation in human subjects, other than a non- interventional trial, which is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the medicinal products identify any adverse reactions to those medicinal products study absorption, distribution, metabolism and excretion of one or more such products  with the objective of ascertaining the safety or efficacy of  those products. Investigational used or assembled in a way different from the form of the product authorised under the authorization these are more useful in new drug development.

  • Track 14-1European Guidelines
  • Track 14-2FDA Guidelines
  • Track 14-3WHO Guidelines

Nutrient Bioavailability refers to the proportion of a nutrient that is absorbed from the diet and used for normal body functions. It includes enhancers of nutrient bioavailability, factors playing a critical role in absorption of nutraceuticals and herbal products. The role of BPDM nutrient bioavailability is discussed under this track.

  • Track 15-1Factors playing a critical role in absorption of nutraceuticals
  • Track 15-2Enhancers of nutrient bioavailability
  • Track 15-3The role of BPDM nutrient bioavailability
  • Track 15-4Bioavailability of nutrients and fed bioequivalence studies

In pharmacology, bioavailability (BA) is a subcategory of ingestion and is the part of a managed measurement of unaltered medication that achieves the systemic flow, one of the important pharmacokinetic properties of medications. Bioavailability is one of the crucial apparatuses in pharmacokinetics, as bioavailability must be considered when computing doses for non-intravenous courses of organization.

  • Track 16-1Application of Nano technology to improve bioavailabilty
  • Track 16-2Innovative strategies
  • Track 16-3Isotope drug studies in man
  • Track 16-4Bioequivalence Criteria
  • Track 16-5Risks in bioequivalence assessment
  • Track 16-6Requirement to determine the active principle
  • Track 16-7SUPAC: scale-up and for post-approval changes
  • Track 16-8Relevance of bioequivalence in approving generic copies of drug products
  • Track 16-9Electronic regulatory submission and review
  • Track 16-10Drug application regulatory compliance
  • Track 16-11New drug quality assessment
  • Track 16-12Highly variable and low permeable drugs
  • Track 16-13Complex generics

A biosimilar is a biologic therapeutic item which is duplicate of a unique item that is produced by an alternate organization. Biosimilars are authoritatively sanction forms of unique "discoverer" items, and can be produced when the first item's patent terminates. Reference to the pioneer item is a fundamental part of the approbation.

The world market of biosimilars is predicted to reach USD 10.90 Billion by 2021 from USD 3.39 Billion in 2016, at a CAGR of 26.3%. The market is classified into product, manufacturing type, application, and region. According to the application, the divisions in the biosimilars market are oncology, chronic and autoimmune diseases, blood disorders, infectious diseases, growth hormone deficiency and other applications.

  • Track 17-1Cancer therapeutics
  • Track 17-2Cardiovascular therapeutics
  • Track 17-3Diabetes therapeutics
  • Track 17-4Adverse drug reactions with pharmaceutical products

Clinical pharmacology is the science of drug use in humans. Clinicians of all specialties pre-scribe drugs on a daily basis, and this is both one of the most useful but also one of the most dangerous activities of our professional lives. This track includes recent developments on behavioural pharmacology, Clinical toxicology, Clinical and experimental pharmacology, Clinical drug developments & therapeutics and also recent developments on posology. Pharmacogenetics is the study of inherited genetic differences in drug metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects which will be discussed under this track.

An overview of the global market of drugs, in addition to coverage of therapeutics such as antibacterial, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs sector is habitual to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

An overview of the global market of drugs, in addition to coverage of therapeutics such as antibacterial, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs sector is habitual to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

  • Track 18-1Recent developments on behavioral pharmacology
  • Track 18-2Clinical toxicology
  • Track 18-3Pharmacogenetics
  • Track 18-4Clinical and experimental pharmacology
  • Track 18-5Clinical drug developments & therapeutics
  • Track 18-6Recent developments on posology