Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient.

Autor: Orr RK; Global Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA. robert.orr@merck.com., Rawalpally T; Regulatory Affairs, Chemistry, Manufacturing and Controls, AstraZeneca BioPharmaceutical Inc., 1 Medimmune Way, Gaithersburg, MD, 20878, USA. thimma.rawalpally@astrazeneca.com., Gorka LS; Global Regulatory Sciences, Chemistry Manufacturing and Controls, Pfizer Inc., Pfizer Research and Development, New York, NY, 10001, USA. lindsey.saunders.gorka@pfizer.com., Bonaga LR; Global Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA., Schenck L; Oral Formulation Sciences, Merck & Co., Inc., Rahway, NJ, 07065, USA., Osborne S; Global Regulatory Affairs - Chemistry, Manufacturing and Controls, Eli Lilly & Company, Indianapolis, Indiana, 46285, USA., Erdemir D; Drug Product Development, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, New Jersey, 08903, USA., Timpano RJ; Global Regulatory Sciences, Chemistry Manufacturing and Controls, Pfizer Inc., Pfizer Research and Development, Groton, CT, 06340, USA., Zhang H; Chemical Process R&D, Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.

Publikováno v: The AAPS journal [AAPS J] 2024 Dec 17; Vol. 27 (1), pp. 16. Date of Electronic Publication: 2024 Dec 17.