These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
160 related articles for article (PubMed ID: 27020644)
1. A Roadmap for the Implementation of Continued Process Verification. Boyer M; Gampfer J; Zamamiri A; Payne R PDA J Pharm Sci Technol; 2016; 70(3):282-92. PubMed ID: 27020644 [TBL] [Abstract][Full Text] [Related]
2. FDA 2011 process validation guidance: lifecycle compliance model. Campbell C PDA J Pharm Sci Technol; 2014; 68(2):185-91. PubMed ID: 24668605 [TBL] [Abstract][Full Text] [Related]
3. A practical discussion of risk management for manufacturing of pharmaceutical products. Mollah AH; Baseman HS; Long M; Rathore AS PDA J Pharm Sci Technol; 2014; 68(3):271-80. PubMed ID: 25188348 [TBL] [Abstract][Full Text] [Related]
4. Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development. Mehta MU; Uppoor RS; Conner DP; Seo P; Vaidyanathan J; Volpe DA; Stier E; Chilukuri D; Dorantes A; Ghosh T; Mandula H; Raines K; Dhanormchitphong P; Woodcock J; Yu LX Mol Pharm; 2017 Dec; 14(12):4334-4338. PubMed ID: 29076742 [TBL] [Abstract][Full Text] [Related]
5. Characterization and establishment of specifications for biopharmaceuticals. Davis GC; Riggin RM Dev Biol Stand; 1997; 91():49-54. PubMed ID: 9413683 [TBL] [Abstract][Full Text] [Related]
6. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing. Jiang M; Severson KA; Love JC; Madden H; Swann P; Zang L; Braatz RD Biotechnol Bioeng; 2017 Nov; 114(11):2445-2456. PubMed ID: 28710854 [TBL] [Abstract][Full Text] [Related]
7. FDA perspective on specifications for biotechnology products--from IND to PLA. Murano G Dev Biol Stand; 1997; 91():3-13. PubMed ID: 9413677 [TBL] [Abstract][Full Text] [Related]
8. Use of benchmarking in the development of biopharmaceutical products. Giffin M; McLeish S Biotechnol Annu Rev; 2003; 9():279-84. PubMed ID: 14650932 [TBL] [Abstract][Full Text] [Related]
9. Appropriate specifications at the IND stage. Geigert J Dev Biol Stand; 1997; 91():39-43. PubMed ID: 9413681 [TBL] [Abstract][Full Text] [Related]
10. Provable Data Integrity in the Pharmaceutical Industry Based on Version Control Systems and the Blockchain. Steinwandter V; Herwig C PDA J Pharm Sci Technol; 2019; 73(4):373-390. PubMed ID: 30770485 [TBL] [Abstract][Full Text] [Related]
11. Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality. O'Connor TF; Yu LX; Lee SL Int J Pharm; 2016 Jul; 509(1-2):492-498. PubMed ID: 27260134 [TBL] [Abstract][Full Text] [Related]