Validating BioAnalytical Methods

The measurement of drug concentrations in biological matrices such as serum, plasma, blood, urine, and saliva is an important aspect of medicinal product development.



Considering such data may be required to support applications for new active substances and generics as well as variations to authorized drug products, understanding this key data is paramount to success.  

As a prerequisite for many steps of the pharma process, bioanalytical methods are typically categorized in three ways. A full validation, for cases when the method is developed and implemented for the first time. A part validation, typically used if previously validated bioanalytical methods have been modified or transferred to another lab. And finally, cross-validation, when two or more bioanalytical methods are used to generate data within the same study.

By understanding the quantitative measurement of a concentration of a drug and its metabolite, a comprehensive report ready for future audit or inspection giving evidence of purity, the identity of drug standards, etc. can be created.

With multiple new validated Bioanalytical methods processed within 2021, including Bazedoxifene, Melatonine, and Sunitinib, and well over 300 methods validated overall, aficionados in this field QUINTA-ANALYTICA are world-renowned as experts in this area of pharmaceutical services.  

Possessing 25-years of experience in the industry, and working across the globe, Quinta’s in-house labs develop and validate in accordance with GLP rules and ICH/FDA and EMA guidelines giving you full confidence in the results.

To find out more, or discuss your requirements speak to the Quinta team.

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