Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Register free: www.pharmtech.com/pt/stability
Sponsored by Patheon
Abstract Background: Lamivudine (3TC), Zidovudine (AZT) and Nevirapine (NVP) are the common antiretrovirals prescribed in resource limited countries due to...
Accelerated stability analysis is a strategy used to quickly evaluate alternative formulations, packaging, and processes. Accelerated linear studies are...
Abstract Cleaning validation (CV) is a Good Manufacturing Practices (GMP) requirement in the manufacturing of drug substances and drug...
Abstract Current standards and regulations demand the pharmaceutical industry not only to produce highly pure drug substances, but to...
F2 parameter is widely used parameter in drug dissolution testings where it is often used to predict similarity of...
Limulus Amoebocyte Lysate (LAL) users are exploring regimens to study the effects of adding endotoxin to undiluted biologics in reaction to Chen’s...
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