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August 10, 2022
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
August 03, 2022
A comprehensive understanding of potential material change can mitigate its impact on patient safety.
The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.
August 02, 2022
Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.
Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.
July 18, 2022
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
July 02, 2022
By understanding potential material change, the impact on patient safety can be understood and mitigated.
An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.
June 03, 2022
This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.
June 02, 2022
When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.