Bioanalysis for plasma protein binding studies in drug discovery and drug development: views and recommendations of the European Bioanalysis Forum
| Autor: | Lieve Dillen, Brigitte Buscher, Klaus Pusecker, Philip Timmerman, Winfried Wagner-Redeker, Thomas Pfeifer, Pascal Delrat, Sirpa Laakso, Hermann Mascher, Mira Doig |
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| Rok vydání: | 2014 |
| Předmět: |
inorganic chemicals
Drug Bioanalysis media_common.quotation_subject Clinical Biochemistry Pharmacology Analytical Chemistry Drug Discovery Medicine Humans General Pharmacology Toxicology and Pharmaceutics media_common Medical education business.industry Drug discovery General Medicine Blood Proteins respiratory system Tiered approach respiratory tract diseases Medical Laboratory Technology Drug development Drug Design business Blood Chemical Analysis Protein Binding |
| Zdroj: | Bioanalysis. 6(5) |
| ISSN: | 1757-6199 |
| Popis: | Plasma protein binding (PPB) is an important parameter for a drug’s efficacy and safety that needs to be investigated during each drug-development program. Even though regulatory guidance exists to study the extent of PPB before initiating clinical studies, there are no detailed instructions on how to perform and validate such studies. To explore how PPB studies involving bioanalysis are currently executed in the industry, the European Bioanalysis Forum (EBF) has conducted three surveys among their member companies: PPB studies in drug discovery (Part I); in vitro PPB studies in drug development (Part II); and in vivo PPB studies in drug development. This paper reflects the outcome of the three surveys, which, together with the team discussions, formed the basis of the EBF recommendation. The EBF recommends a tiered approach to the design of PPB studies and the bioanalysis of PPB samples: ‘PPB screening’ experiments in (early) drug discovery versus qualified/validated procedures in drug development. |
| Databáze: | OpenAIRE |
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