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. |
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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 |
Externí odkaz: |