In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...
A sustainable UV-spectrophotometric method coupled with bio-inspired chemometric algorithms was developed for simultaneous quantification of three COVID-19 antivirals — molnupiravir, nirmatrelvir, and ...
Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...
Epilepsy is a chronic neurological disease that affects the brain and causes a recurrent seizure. This condition affects a lot of people worldwide making it a global neurological disorder. The first ...
Realize safe, scalable, and compliant cell therapies by building analytical strategies that exceed regulatory expectations.
In pharmaceutical organizations, developing and validating chromatographic methods is a routine, yet resource-intensive, task. Once a method is optimized and performs reliably, it’s natural to expect ...
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
A randomized, multicenter clinical trial to determine the efficacy and safety of pegfilgrastim (GEMA BIOTECH) compared to pegfilgrastim (Roche) for prevention of chemotherapy induced neutropenia in ...
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