Historically, the development of perceptive and precise bio analytical approach in the 1960s and 1970s was allowed for the first time, the measurement of very low levels of drug concentrations in biological fluids. Correspondingly, pharmacokinetic profiles of drugs, describing absorption, distribution, and clearance, could be determined. Regulations related to bioavailability and bioequivalence were put into place, considering the latest advances in the science. A significant role in the discovery, development, and regulation of new drug products involves in recent research of Bioavailability and Bioequivalence. a crucial component of abbreviated new drug applications (ANDAs), leading to market access of safe, effective, and low cost in the advance studies of bioequivalence
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.
The bio similar segment is one of the fastest growing segments and is likely to reach more than USD 25 billion by 2020. Despite high development costs, the bio similar segment is likely to witness rapid growth due to the rising number of off-patent biologic drugs. The growth of this sector is attributed to the positive outcomes of on-going clinical trials and the growing demand for bio similar in different therapeutic applications. The application of advanced technologies such as recombinant DNA technology, genetic engineering, and combinatorial chemistry has increased the entry of novel biopharmaceuticals in the market which will contribute to this segment’s growth over the next four years.
Drug Metabolism conference is a platform to have all the scientific eminent across the globe. 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 pro drug (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.
Bioavailability is one of the essential tools in Pharmacokinetics, as bioavailability must be considered when calculating dosages for no intravenous routes of administration. An appropriate BE method often needs to be established based on a scientific analysis of each drug product. The above was a brief overview of bioavailability study protocol with some of its specification and essential features. Bioavailability or Bioequivalence which is actually the heart and soul of therapeutic response of a drug moiety in a given drug product.
Human pharmacokinetic in vivo studies are often presumed to serve as the “gold standard” to assess product bioequivalence (BE) of immediate-release (IR) solid oral dosage forms. However, when this general assumption is re-visited, it appears that in vitro studies are sometimes better than in vivo studies in assessing BE of IR solid oral dosage forms. Reduced costs are achieved through avoiding in vivo studies where BE is self-evident, where biopharmaceutical data anticipates BE, and where in vivo BE study type II error is high. Sponsors of potential in vivo human pharmacokinetic BE testing should be required to justify why in vitro data is insufficient, similar to proposed animal testing requires justification to not employ an in vitro approach.
Drug product performance is a vital aspect of drug development as it draws on interdisciplinary expertise from both pharmaceutics and pharmacokinetics disciplines. It is at the key interface that the discipline of bio pharmaceutics has emerged. The past two decades have witnessed considerable advances in bio pharmaceutics particularly with regard to bioavailability and bioequivalence, as they relate to product quality and regulatory standards of approval.
Pharmaceuticals Formulation conference is a platform to have all the scientific eminent across the globe. Drug product formulation is at the core of Particle Sciences. Industry-wide, delivery of active pharmaceutical ingredients (APIs) has taken center stage along with the API's themselves. Focused initially on problematic new chemical entities (NCEs), delivery systems are now the go-to approach for both NCE commercialization and the refinement and repurposing of existing APIs. The biological and chemical needs generally fall into one or a combination of a small number of categories. In addition to physicochemical and physiologic goals, business concerns also drive the use of sophisticated drug delivery systems. Intellectual property, life-cycle management, cost and market differentiations are examples.
Pharmacodynamics and pharmacokinetics conference is a platform to have all the scientific eminent across the globe. 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. 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.
Biowaivers conference is a platform to have all the scientific eminent across the globe. 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.
Drug discovery process basically is a patient oriented science, where researchers strive to improve the existing drugs or invent a totally new chemical entity, which should be ideally more potent than any existing drug of a similar category. If not, then at least it should be safer than those existing. This process is a very time consuming and expensive activity, calling for the expertise of many eminent researchers. It takes nearly 12-14 years of exhaustive research and a huge amount of financial investment for the discovery of a single drug
Failure at any stage would mean a huge loss for the company. Hence, a lot of planning is required even before the project is underway. Recently, with the use of technology the process is becoming a less risky business, because of the ability of the computers to predict the possible outcomes. This will surely reduce the efforts in fruitless directions. Hence, the most important and most common biological targets for drug discovery are either enzymes regulating the biochemistry or the receptors through which many hormones and endogenous effectors show their response.
Entrepreneur Meet is a platform to bring all the eminent speakers and researchers together in this conference The decision to terminate a trial early due to unacceptable toxicity or substantial and convincing evidence of benefit is complex and must account for many factors These include possible imbalances in risk factors between treatment groups, whether the patients have the risk profile assumed in the design, patient compliance to therapy, quality and timeliness of data, possible sources of bias, consistency of primary and secondary outcome variables, the benefit-to-risk ratio, consistency of results with external data, and the impact of early termination on the medical community as well as the public. Evaluation of these issues goes beyond routine statistical tests and requires the collective judgment of experts, such as those represented by a DSMB. For decades the creation of new medicines has increased quality and quantity of life for patients around the globe.