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

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...

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Detalles Bibliográficos
Autores principales: Van Buskirk, Glenn A., Asotra, Satish, Balducci, Christopher, Basu, Prabir, DiDonato, Gerald, Dorantes, Angelica, Eickhoff, W. Mark, Ghosh, Tapash, González, Mario A., Henry, Theresa, Howard, Matthew, Kamm, Jason, Laurenz, Steven, MacKenzie, Ryan, Mannion, Richard, Noonan, Patrick K., Ocheltree, Terrance, Pai, Umesh, Poska, Richard P., Putnam, Michael L., Raghavan, Ramani R., Ruegger, Colleen, Sánchez, Eric, Shah, Vinod P., Shao, Zezhi Jesse, Somma, Russell, Tammara, Vijay, Thombre, Avinash G., Thompson, Bruce, Timko, Robert J., Upadrashta, Satyam, Vaithiyalingam, Sivakumar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2014
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4037495/
https://www.ncbi.nlm.nih.gov/pubmed/24578237
http://dx.doi.org/10.1208/s12249-014-0087-x

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