Meaning of Pharmacokinetics in Drug Development

Pharmacokinetics is the study of drug absorption, distribution, metabolism, and excretion. A fundamental concept in pharmacokinetics is drug clearance, that is, elimination of drugs from the body, analogous to the concept of creatinine clearance.

The word pharmacokinetics definition is derived from the words “pharmaco” meaning ‘drug’, and “kinetics” which means ‘movement’ . As its name implies, PK deals with the movement of drugs within an organism. Its primary objective is to determine the fate of a drug once administered into an organism (i.e., in vivo). Pharmacokinetic quantifies the dynamic processes underlying absorption, distribution, metabolism and excretion of a drug substance from its site of administration to its site of action or elimination. Pharmacokinetics or PK is the study of the absorption, distribution, metabolism and excretion of pharmaceutical agents (or drugs). The understanding of these principles allows for rational approaches to drug choice and dose selection.

Pharmacokinetics (abbreviated as PK) is a branch of pharmacology dedicated to determine the fate of substances administered to a living organism. The substances of interest include any chemical xenobiotic such as: pharmaceutical drugs, pesticides, food additives, cosmetics, etc. It attempts to analyze chemical metabolism and to discover the fate of a chemical from the moment that it is administered up to the point at which it is completely eliminated from the body.

At NorthEast BioLab, we aim to deliver quality preclinical drug development services with focus on your unique needs. We consider our selves a partner of your drug discovery program and work with you as a team on bringing your product to market.The Food and Drug Administration (FDA) approves drugs for sale in the U.S. after carefully reviewing a drug’s safety and effectiveness. The FDA has specific processes and standards for ensuring safety, efficacy and quality of a drug, before it is approved for the market. Below, we have attempted to put together a simple, quick step-by-step version of the FDA’s process for new drug approval in the US.

In our work on assay development in drug discovery , we use sponsored animal models and analytical testing services to help in the development of innovative drugs and therapies. The complexity of product development has increased manifolds over the past 40 years, requiring preclinical testing, investigational new drug (IND) applications, and completed clinical testing before marketing approval from the FDA. Generally, new drug applications (NDAs) or biologics license applications (BLA) are reviewed comprehensively before approval, and then drug performance is resubmitted to regulatory agencies for post-marketing studies. The overarching goal is to bring more efficient and safer treatments to the patients as quickly as possible after a thorough medical evaluation.

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. One crucial step during this development pathway is the preclinical testing which aims to identify any potential toxicities, efficacy and side effects of a candidate drug. It typically involves animal studies, to monitor whether or not a candidate drug causes any lethal or life-threatening symptoms before progressing further into human trials. Therefore, identifying methods for high throughput toxicity testing that does not require animals is essential for successful and efficient drug development. The focus on human health care remains the top priority for all companies, in which case human cell-based assays have become the leading model for non-animal drug testing. The search for more efficient and safer treatment requires thorough medical evaluations, hence why cytokine based assays are widely used to study the effects of a pharmaceutical agent on an organism.

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By Michael Caine

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