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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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