Pharmacokinetics in drug discovery and development pdf

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pharmacokinetics in drug discovery and development pdf

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Drug Metabolism and Pharmacokinetics (DMPK)

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. Corpus ID: Role of pharmacokinetics and metabolism in drug discovery and development. Lin and A. Lin , A.

Applied Pharmacokinetics in Drug Development

How long do you think it takes for a new drug to get approved in the US? Next, how much investment do you think is required to bring a new drug to market? Simply put, approval of a new drug is a massive undertaking and selecting the right partners, who prioritize in sync with you and focus on high quality and fast turnaround, goes a long way in avoiding missteps and moving your drug program closer to success. The complexity in drug 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. There are five critical steps in the U.

The process of discovering, developing, and marketing new drugs has changed considerably in the last decade; however, the cost associated with this process remains staggeringly high. Although there are many reasons for this high cost, one reason appears to be the continuing high attrition rates of drugs during costly early- and late-stage human clinical trials. To address this problem, drug discovery organizations are striving to rapidly identify high-potential drug candidates and eliminate as early as possible those with inferior potency, poor pharmacokinetic properties, and toxicity problems, so that these deficient drug candidates do not incur the high costs of clinical trials. Pharmacological deficiencies are related in part to pharmacokinetic properties. To understand this process, a brief review of pharmacokinetic properties including oral bioavailability, half-life, absorption, clearance, and volume of distribution is presented. This is a preview of subscription content, access via your institution.

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. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. New chemical entities NCEs, also known as new molecular entities or NMEs are compounds that emerge from the process of drug discovery. These have promising activity against a particular biological target that is important in disease. However, little is known about the safety, toxicity , pharmacokinetics , and metabolism of this NCE in humans. It is the function of drug development to assess all of these parameters prior to human clinical trials.

Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management.

Stages of Drug Development

Characterizing the relationship between the pharmacokinetics PK, concentration vs. Specific examples and case studies are highlighted to help demonstrate key points for consideration. In some cases pharmacokinetics are not determined in the same animals used in the PD study.

The intention of this chapter is to provide an overview of how pharmacokinetics, also termed PK, is applied in early drug development. While there are many readily available printed and web accessible sources on pharmacokinetics, its technical terms, model definitions, and calculation methods; how the science of pharmacokinetics is used in specific situations, namely early drug development are not as readily covered. In fact, the reader will see that the continual theme in this chapter is that a small amount of pharmacokinetic data and its interpretation in the first nonclinical or clinical study is important in obtaining additional pharmacokinetic, safety, and efficacy information for the next study.

Any drug development process must proceed through several stages in order to produce a product that is safe, efficacious, and has passed all regulatory requirements. Pacific BioLabs can assist you through all stages of drug developoment. Our scientists can help you to determine your testing needs, and our experienced staff can perform the critical tests and studies that are necessary to win FDA approval.


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