Late phase clinical research has become a growing focus for regulators, CROs and biopharmaceutical and medical device companies. Increasing requirements for long-term safety and effectiveness of data collection during the peri-approval and post-marketing periods pose both challenges and ...
Among the challenges involved in developing acceptable commercial dosage forms for active pharmaceutical ingredients (API’s) is demonstrating adequate chemical stability [1,2]. Expiration dating is generally determined based on the time a drug product remains within specification limits of potency ...
Often ideas are generated but little is done on the follow-up to bring them to fruition. The purpose of this paper is to support the final stage of the Bow Tie Method- the management proposal.
CTPAT, CCSP, CSI, FAST, ISF and AEO; what do these collection of letters all have in common? Security; specifically they are all government-sponsored supply chain security programs.
Ligand binding assays (LBAs) are the primary methods used to quantify biotherapeutics, biomarkers and anti-drug antibodies to support biotherapeutics development. LBAs have been proven more difficult to outsource owing to their unique challenges such as high assay variability, nonlinear calibration,...
In this era of mergers and acquisitions, collaborative manufacturing partnerships, and increasing numbers of outsourcing deals, the biopharmaceutical industry faces the challenge of adopting the best externalization strategies that are financially sound, and that ensure adequate oversight without ...