博客 - Based on industry feedback following the recent requirements regarding risk assessments of marketed products, a significant amount of small molecule related APIs, possibly 30%+, have been shown to have the potential to form active related nitrosamines
博客 - AMS Science Lead Mike Ludlow explains the importance of good experimental design for extractable and leachable studies.
博客 - An understanding of the characteristics of drug exposure following administration and how it relates to safety and efficacy is critical for progressing drug development (e.g. in decision making for drug candidates, design of dosing regimens and making predictions for future studies) as well as being a requirement for regulatory authorities. Pharmacokinetics (PK) analysis aims to evaluate quantitatively how a drug enters the body, what happens to the drug while in the body and ultimately, how it is removed. These processes are commonly referred to by the acronym ‘ADME’, which comprises absorption, distribution, metabolism and excretion.