270 related articles for article (PubMed ID: 30361288)
21. Use of the permitted daily exposure (PDE) concept for contaminants of intravitreal (IVT) drugs in multipurpose manufacturing facilities.
Lovsin Barle E; Pfister T; Fux C; Röthlisberger D; Jere D; Mahler HC
Regul Toxicol Pharmacol; 2019 Feb; 101():29-34. PubMed ID: 30367903
[TBL] [Abstract][Full Text] [Related]
22. Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy.
Araya S; Pfister T; Blum K; Clemann N; Faltermann S; Wiesner L; Hawkins W; van de Gevel I; Versyck K
Regul Toxicol Pharmacol; 2023 Aug; 142():105430. PubMed ID: 37308050
[TBL] [Abstract][Full Text] [Related]
23. Assessment of Extractable Elements from Elastomers.
Paskiet D; Kraft C; Tullo E; Hunter J; Zurbriggen D
PDA J Pharm Sci Technol; 2019; 73(1):83-91. PubMed ID: 30030347
[TBL] [Abstract][Full Text] [Related]
24. Multiproduct Resin Reuse for Clinical and Commercial Manufacturing-Methodology and Acceptance Criteria.
Sharnez R; Doares S; Manning S; Mehta K; Mahajan E; To A; Daniels W; Glynn J; Dhamane S; Wen X; Wang Y; Gour P; Guenther C; Foley D; Hayes R; Mott A; Prabhu S; Tavalsky D; Hendershot M; Haas D; Hesslein A; Schuelke N; Tjandra H
PDA J Pharm Sci Technol; 2018; 72(6):584-598. PubMed ID: 30030349
[TBL] [Abstract][Full Text] [Related]
25. Equipment and analytical companies meeting continuous challenges. May 20-21, 2014 Continuous Manufacturing Symposium.
Page T; Dubina H; Fillipi G; Guidat R; Patnaik S; Poechlauer P; Shering P; Guinn M; Mcdonnell P; Johnston C
J Pharm Sci; 2015 Mar; 104(3):821-31. PubMed ID: 25448273
[TBL] [Abstract][Full Text] [Related]
26. Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning.
Olson MJ; Faria EC; Hayes EP; Jolly RA; Barle EL; Molnar LR; Naumann BD; Pecquet AM; Shipp BK; Sussman RG; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S19-27. PubMed ID: 27233923
[TBL] [Abstract][Full Text] [Related]
27. Recent developments in the risk assessment of potentially genotoxic impurities in pharmaceutical drug substances.
Humfrey CD
Toxicol Sci; 2007 Nov; 100(1):24-8. PubMed ID: 17656486
[TBL] [Abstract][Full Text] [Related]
28. Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.
Barone PW; Avgerinos S; Ballard R; Brussel A; Clark P; Dowd C; Gerentes L; Hart I; Keumurian FJ; Kindermann J; Leung JC; Ly N; Mink S; Minning S; Mullberg J; Murphy M; Nöske K; Parriott S; Shum B; Wiebe ME; Springs SL
PDA J Pharm Sci Technol; 2019; 73(2):191-203. PubMed ID: 30361281
[TBL] [Abstract][Full Text] [Related]
29. Application of total organic carbon analysis to cleaning validation.
Jenkins KM; Vanderwielen AJ; Armstrong JA; Leonard LM; Murphy GP; Piros NA
PDA J Pharm Sci Technol; 1996; 50(1):6-15. PubMed ID: 8846061
[TBL] [Abstract][Full Text] [Related]
30. Challenges in setting permitted daily exposure limits for pharmaceuticals: A review.
Ahuja V; Krishnappa M
Int J Risk Saf Med; 2022; 33(1):49-64. PubMed ID: 34924402
[TBL] [Abstract][Full Text] [Related]
31. Determination of compound-specific acceptable daily intakes for 11 mutagenic carcinogens used in pharmaceutical synthesis.
Ellis P; Kenyon M; Dobo K
Regul Toxicol Pharmacol; 2013 Mar; 65(2):201-13. PubMed ID: 23228434
[TBL] [Abstract][Full Text] [Related]
32. Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation.
Ma J; Kreil TR
PDA J Pharm Sci Technol; 2018; 72(5):511-515. PubMed ID: 30030359
[TBL] [Abstract][Full Text] [Related]
33. 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]
34. Sampling Error of TOC swab in Pharmaceutical Cleaning Verification.
Jul-Jørgensen I; Hundahl CA; Skibsted E; Gernaey KV
J Pharm Biomed Anal; 2022 Jun; 215():114763. PubMed ID: 35462283
[TBL] [Abstract][Full Text] [Related]
35. 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]
36. Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing.
Stauffer F; Vanhoorne V; Pilcer G; Chavez PF; Rome S; Schubert MA; Aerts L; De Beer T
Eur J Pharm Biopharm; 2018 Jun; 127():92-103. PubMed ID: 29452241
[TBL] [Abstract][Full Text] [Related]
37. Charting and Evaluation of Environmental Microbial Monitoring Data.
Bar R
PDA J Pharm Sci Technol; 2015; 69(6):743-61. PubMed ID: 26659105
[TBL] [Abstract][Full Text] [Related]
38. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity.
Müller L; Mauthe RJ; Riley CM; Andino MM; Antonis DD; Beels C; DeGeorge J; De Knaep AG; Ellison D; Fagerland JA; Frank R; Fritschel B; Galloway S; Harpur E; Humfrey CD; Jacks AS; Jagota N; Mackinnon J; Mohan G; Ness DK; O'Donovan MR; Smith MD; Vudathala G; Yotti L
Regul Toxicol Pharmacol; 2006 Apr; 44(3):198-211. PubMed ID: 16412543
[TBL] [Abstract][Full Text] [Related]
39. Cleaning validation: quantitative estimation of atorvastatin in production area.
Moradiya MR; Solanki KP; Shah PA; Patel KG; Thakkar VT; Gandhi TR
PDA J Pharm Sci Technol; 2013; 67(2):164-71. PubMed ID: 23569077
[TBL] [Abstract][Full Text] [Related]
40. Industry perspective on the medical risk of visible particles in injectable drug products.
Bukofzer S; Ayres J; Chavez A; Devera M; Miller J; Ross D; Shabushnig J; Vargo S; Watson H; Watson R
PDA J Pharm Sci Technol; 2015; 69(1):123-39. PubMed ID: 25691720
[No Abstract] [Full Text] [Related]
[Previous] [Next] [New Search]
