Browsing: Drug development

Drug development begins when a lead compound has been identified in a drug discovery process; it involves multiple stages that are required to bring a new pharmaceutical drug to market.

The earliest stages of drug development involve preclinical studies to determine a candidate’s safety profile. However, the drug development process includes product characterization, formulation, delivery, packaging development, pharmacokinetics, pharmacodynamics, ADME, preclinical toxicology and finally clinical trials.

Clinical trials are made up of different phases, phases I – IV, with each phase recruiting more participants. Phase I looks to assess the safety of a drug or device. Phase II aims to test the efficacy and phase III studies involve randomized blind testing on large sample groups. Phase IV involves post marketing surveillance.

Bioanalytical studies and bioanalytical method development support most stages in the drug development process. This includes the appropriate characterization of molecules, assay development and optimal method development. Bioanalysis supports pre-clinical testing and clinical trials as well as quality assurance and quality control for the entire development process.

 

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What are biologics? In this article, we explore the definitions, potential applications, benefits and ever-changing regulations of this growing family of therapeutics.

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In this Learn with Lin article, Zone Leader Lin Wang (Covance, NJ, USA) explores some of the key terms in LC–MS that form the foundations of a good understanding of the bioanalytical applications of this technique.

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In this interview we caught up with Hua Li (Boehringer Ingelheim Pharmaceuticals, CT, USA) to discuss her research and the inspiration for her 2018 Bioanalysis publication concerning the use of Mitra® microsampling for PK bioanalysis of monoclonal antibodies.

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Much of the science and healthcare news during these dire times has been disheartening. But there’s been at least one encouraging development: new COVID-19 vaccines are on track to be the fastest ever to market. And that accelerated pace might become the new normal.

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