As regulatory expectations continue to evolve, in vitro methodologies like IVRT and IVPT are rapidly becoming the preferred tools for demonstrating bioequivalence (BE) of topically applied generic drugs.
Read More “Redefining Bioequivalence for Topical Drug Products: The Case for In Vitro Methodologies in ANDA Submissions”Diteba Inc. has received FDA Bioequivalence (BE) approval for the IVPT study conducted on Penciclovir Cream 1%. The IVPT method is an essential biowaiver tool for evaluating bioequivalence in generic dermal and transdermal products.
Read More “FDA Bioequivalence (BE) approval for the IVPT study conducted on Penciclovir Cream 1%”Nitrosamine impurities have been a concern within the pharmaceutical industry and by regulatory authorities worldwide since June 2018, when regulators were informed of the presence of N-nitrosodimethylamine (NDMA) in the angiotensin-II receptor blocker (ARB) medicine, valsartan (1).
Read More “Nitrosamine Impurities in Pharmaceuticals: Ensuring Safety and Compliance”Bioanalysis is crucial for assessing drug efficacy and safety throughout the drug development process. It enables researchers to make informed decisions and improve patient outcomes in the pharmaceutical industry.
Read More “Bioanalysis in Drug Discovery and Development, and Diagnosis”This updated edition builds upon our previous publication by incorporating the latest industry guidelines from the US FDA and USP, along with our own practical experiences and direct communications with the FDA. It serves as a valuable resource designed to guide industry professionals through the complexities of IVRT and IVPT methodologies with contemporary insights and regulatory standards.
Read More “New IVRT/IVPT eBook”
