PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes.

Autor: Ramnarine E; Genentech eramnar@gene.com., Busse U; Novartis., Colao M; GlaxoSmithKline Biologicals., Edwards J; Biogen., O'Donnell K; Health Products Regulatory Authority (HPRA), Ireland., Jornitz M; G-Con, LLC., Munk M; NNE Pharmaplan., Seymour M; Biogen., Simianu M; Pharmatech Associates., Skeens L; Pfizer., Vinther A; Sanofi-Pasteur.
Jazyk: angličtina
Zdroj: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2017 May-Jun; Vol. 71 (3), pp. 252-258. Date of Electronic Publication: 2017 Feb 14.
DOI: 10.5731/pdajpst.2017.007575
Databáze: MEDLINE