1. Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.
- Author
-
Van Buskirk GA, Asotra S, Balducci C, Basu P, DiDonato G, Dorantes A, Eickhoff WM, Ghosh T, González MA, Henry T, Howard M, Kamm J, Laurenz S, MacKenzie R, Mannion R, Noonan PK, Ocheltree T, Pai U, Poska RP, Putnam ML, Raghavan RR, Ruegger C, Sánchez E, Shah VP, Shao ZJ, Somma R, Tammara V, Thombre AG, Thompson B, Timko RJ, Upadrashta S, and Vaithiyalingam S
- Subjects
- Animals, Chemistry, Pharmaceutical standards, Delayed-Action Preparations standards, Drug Approval, Drug Industry methods, Excipients chemistry, Excipients standards, Humans, Pharmaceutical Preparations administration & dosage, Pharmaceutical Preparations chemistry, Pharmacokinetics, Quality Control, Risk Assessment, Solubility, Technology, Pharmaceutical methods, Toxicology standards, United States, United States Food and Drug Administration, Benchmarking standards, Drug Industry standards, Pharmaceutical Preparations standards, Technology, Pharmaceutical standards
- Abstract
In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.
- Published
- 2014
- Full Text
- View/download PDF