270 related articles for article (PubMed ID: 29631666)
1. Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.
Tabersky D; Woelfle M; Ruess JA; Brem S; Brombacher S
Chimia (Aarau); 2018 Mar; 72(3):146-150. PubMed ID: 29631666
[TBL] [Abstract][Full Text] [Related]
2. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.
Allison G; Cain YT; Cooney C; Garcia T; Bizjak TG; Holte O; Jagota N; Komas B; Korakianiti E; Kourti D; Madurawe R; Morefield E; Montgomery F; Nasr M; Randolph W; Robert JL; Rudd D; Zezza D
J Pharm Sci; 2015 Mar; 104(3):803-12. PubMed ID: 25830179
[TBL] [Abstract][Full Text] [Related]
3. [Pharmaceutical product quality control and good manufacturing practices].
Hiyama Y
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2010; (128):1-16. PubMed ID: 21381389
[TBL] [Abstract][Full Text] [Related]
4. The regulatory framework for preventing cross-contamination of pharmaceutical products: History and considerations for the future.
Sargent EV; Flueckiger A; Barle EL; Luo W; Molnar LR; Sandhu R; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S3-S10. PubMed ID: 27230736
[TBL] [Abstract][Full Text] [Related]
5. Organic solvents in the pharmaceutical industry.
Grodowska K; Parczewski A
Acta Pol Pharm; 2010; 67(1):3-12. PubMed ID: 20210074
[TBL] [Abstract][Full Text] [Related]
6. Campaign manufacturing of highly active or sensitizing drugs: a comparison between the GMPs of various Regulatory Agencies.
Petrelli F; Scuri S; Grappasonni I; Nguyen CTT; Cocchini A; Magrini E; Caraffa A
Clin Ter; 2020; 170(1):e66-e73. PubMed ID: 31850487
[TBL] [Abstract][Full Text] [Related]
7. [Demonstration of quality, safety and efficacy of biological products subject to changes in their manufacturing process].
Vasil'ev AN; Gavrishina EV; Niiazov RR; Snegireva AA; Adonin VK
Antibiot Khimioter; 2013; 58(9-10):45-55. PubMed ID: 24738243
[TBL] [Abstract][Full Text] [Related]
8. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
Giordani A; Kobel W; Gally HU
Eur J Pharm Sci; 2011 May; 43(1-2):1-15. PubMed ID: 21420491
[TBL] [Abstract][Full Text] [Related]
9. Current good manufacturing practice: proposed revision of certain requirements for finished pharmaceuticals; proposed rule, May 3, 1996 (61 FR 20103), [Docket No. 95N-0362]. Parenteral Drug Association.
PDA J Pharm Sci Technol; 1996; 50(6):346-51. PubMed ID: 9038078
[No Abstract] [Full Text] [Related]
10. Evaluation of similar biotherapeutic products: scientific and regulatory challenges.
Griffiths E; Thorpe R; Wadhwa M; Sohn Y
Biologicals; 2011 Sep; 39(5):249. PubMed ID: 21925898
[No Abstract] [Full Text] [Related]
11. Pharmaceutical GMP: past, present, and future--a review.
Patel KT; Chotai NP
Pharmazie; 2008 Apr; 63(4):251-5. PubMed ID: 18468382
[TBL] [Abstract][Full Text] [Related]
12. Data Integrity: History, Issues, and Remediation of Issues.
Rattan AK
PDA J Pharm Sci Technol; 2018; 72(2):105-116. PubMed ID: 29158286
[TBL] [Abstract][Full Text] [Related]
13. Quality control and good manufacturing practices: safety and efficacy of commercial herbals.
Awang DV
Food Drug Law J; 1997; 52(3):341-4. PubMed ID: 10343036
[No Abstract] [Full Text] [Related]
14. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.
Myerson AS; Krumme M; Nasr M; Thomas H; Braatz RD
J Pharm Sci; 2015 Mar; 104(3):832-9. PubMed ID: 25546650
[TBL] [Abstract][Full Text] [Related]
15. The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices.
Petrelli F; Caraffa A; Scuri S; Grappasonni I; Magrini E; Cocchini A
Acta Biomed; 2019 May; 90(2):288-299. PubMed ID: 31125009
[TBL] [Abstract][Full Text] [Related]
16. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
Pflieger M; Bertram D
Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
[TBL] [Abstract][Full Text] [Related]
17. The regulatory framework for similar biotherapeutic products in Cuba.
Hechavarría Núñez Y; Pérez Massipe RO; Orta Hernández SD; Muñoz LM; Jacobo Casanueva OL; Pérez Rodríguez V; Domínguez Morales RB; Pérez Cristiá RB
Biologicals; 2011 Sep; 39(5):317-20. PubMed ID: 21930393
[TBL] [Abstract][Full Text] [Related]
18. [Accession to the PIC/S and pharmaceutical quality system in Japan].
Katori N
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2014; (132):22-35. PubMed ID: 25707200
[TBL] [Abstract][Full Text] [Related]
19. Regulatory guideline for biosimilar products in Korea.
Suh SK; Park Y
Biologicals; 2011 Sep; 39(5):336-8. PubMed ID: 21784653
[TBL] [Abstract][Full Text] [Related]
20. Managing the microbiological quality of pharmaceutical excipients.
Cundell AM
PDA J Pharm Sci Technol; 2005; 59(6):381-95. PubMed ID: 16471425
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
