270 related articles for article (PubMed ID: 30361288)
1. Cleaning Validation: Complete Guide for Health - Based Approach in Chemical Cross - Contamination Risk Assessment.
Tanyous JN
PDA J Pharm Sci Technol; 2019; 73(2):204-210. PubMed ID: 30361288
[TBL] [Abstract][Full Text] [Related]
2. Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts.
Denk R; Flückiger A; Kisaka H; Krause S; Maeck R; Restetzki L; Schreiner A; Schulze R
PDA J Pharm Sci Technol; 2019; 73(5):487-495. PubMed ID: 31420508
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE).
Wiesner L; Prause M; Lovsin Barle E
Pharm Dev Technol; 2018 Mar; 23(3):261-264. PubMed ID: 28535123
[TBL] [Abstract][Full Text] [Related]
5. A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.
Hayes EP; Jolly RA; Faria EC; Barle EL; Bercu JP; Molnar LR; Naumann BD; Olson MJ; Pecquet AM; Sandhu R; Shipp BK; Sussman RG; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S39-47. PubMed ID: 27267172
[TBL] [Abstract][Full Text] [Related]
6. Special endpoint and product specific considerations in pharmaceutical acceptable daily exposure derivation.
Gould J; Callis CM; Dolan DG; Stanard B; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S79-93. PubMed ID: 27233924
[TBL] [Abstract][Full Text] [Related]
7. Comparison of permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs) - Evidence of a robust approach.
Sehner C; Bernier T; Blum K; Clemann N; Glogovac M; Hawkins WA; Kohan M; Linker F; Lovsin-Barle E; Osadolor O; Pfister T; Schulze E; Schwind M; Tuschl G; Wiesner L
Regul Toxicol Pharmacol; 2024 Jun; 150():105649. PubMed ID: 38782234
[TBL] [Abstract][Full Text] [Related]
8. Advancing toxicology in RiskMAPP: setting ADEs based on the subsequent drug substance.
Bercu JP; Sharnez R; Dolan DG
Regul Toxicol Pharmacol; 2013 Feb; 65(1):157-61. PubMed ID: 22921793
[TBL] [Abstract][Full Text] [Related]
9. Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials.
Bercu JP; Dolan DG
Regul Toxicol Pharmacol; 2013 Feb; 65(1):162-7. PubMed ID: 22732128
[TBL] [Abstract][Full Text] [Related]
10. Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities.
Lovsin Barle E; Bizec JC; Glogovac M; Gromek K; Winkler GC
Pharm Dev Technol; 2018 Mar; 23(3):225-230. PubMed ID: 28361586
[TBL] [Abstract][Full Text] [Related]
11. Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products.
Jenke D
PDA J Pharm Sci Technol; 2015; 69(6):677-712. PubMed ID: 26659101
[TBL] [Abstract][Full Text] [Related]
12. Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs).
Bercu JP; Morinello EJ; Sehner C; Shipp BK; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S48-56. PubMed ID: 27233925
[TBL] [Abstract][Full Text] [Related]
13. Cleaning validation of ofloxacin on pharmaceutical manufacturing equipment and validation of desired HPLC method.
Arayne MS; Sultana N; Sajid SS; Ali SS
PDA J Pharm Sci Technol; 2008; 62(5):353-61. PubMed ID: 19055231
[TBL] [Abstract][Full Text] [Related]
14. What to consider for a good quality PDE document?
Sehner C; Schwind M; Tuschl G; Lovsin Barle E
Pharm Dev Technol; 2019 Sep; 24(7):803-811. PubMed ID: 30865481
[TBL] [Abstract][Full Text] [Related]
15. Gamma sterilization of pharmaceuticals--a review of the irradiation of excipients, active pharmaceutical ingredients, and final drug product formulations.
Hasanain F; Guenther K; Mullett WM; Craven E
PDA J Pharm Sci Technol; 2014; 68(2):113-37. PubMed ID: 24668600
[TBL] [Abstract][Full Text] [Related]
16. PDE concept for controlling cleaning agent residues in pharmaceuticals- A critical analysis.
Araya S; Pfister T; Gromek K; Hawkins W; Thomsen ST; Clemann N; Faltermann S; Wiesner L
Regul Toxicol Pharmacol; 2022 Feb; 128():105095. PubMed ID: 34890761
[TBL] [Abstract][Full Text] [Related]
17. Identifying and assessing highly hazardous drugs within quality risk management programs.
Sussman RG; Schatz AR; Kimmel TA; Ader A; Naumann BD; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S11-8. PubMed ID: 27267171
[TBL] [Abstract][Full Text] [Related]
18. Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct Facilities.
Che PL; Bailey AP; Tam CYJ; Alvarez M; Arroyo AY
PDA J Pharm Sci Technol; 2020; 74(4):377-393. PubMed ID: 32179711
[TBL] [Abstract][Full Text] [Related]
19. Using default methodologies to derive an acceptable daily exposure (ADE).
Faria EC; Bercu JP; Dolan DG; Morinello EJ; Pecquet AM; Seaman C; Sehner C; Weideman PA
Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S28-38. PubMed ID: 27233926
[TBL] [Abstract][Full Text] [Related]
20. Guidance on the establishment of acceptable daily exposure limits (ADE) to support Risk-Based Manufacture of Pharmaceutical Products.
Sargent EV; Faria E; Pfister T; Sussman RG
Regul Toxicol Pharmacol; 2013 Mar; 65(2):242-50. PubMed ID: 23291300
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]