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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With the reality of Brexit already impacting the UK’s clinical trials environment, Zamas Lam (QPS; DE, USA) discusses the effect this will have on bioanalytical research, and suggests 10 questions to ask when relocating UK-based preclinical and bioanalysis research projects.

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In this editorial Yu Shrike Zhang (Harvard Medical School; MA, USA), a previous finalist of the Bioanalysis Rising Star Award, discusses his research and hopes for the future. He details the emergence of organ-on-a-chip systems and how these platforms reproduce tissue functions outside the human body.

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Find out more about the technologies involved in drug metabolism and what the future may hold for drug metabolism studies in drug discovery research in this ‘In the Zone’ feature.

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As part of our ‘In the Zone’ feature on drug metabolism, we present the top 6 tips for LC–MS for drug metabolism studies. Find out more about best practice tip and tricks for LC–MS in this helpful infographic from MilliporeSigma (MO, USA).

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