151 related articles for article (PubMed ID: 34924402)
1. 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]
2. 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]
3. Deriving harmonised permitted daily exposures (PDEs) for paracetamol (acetaminophen) CAS #: 103-90-2.
Gromek K; Hawkins W; Bernier T; Sehner C; Zeller E; Schwind M; Pfister T; Kohan M; Osadolor O; Glogovac M; Tuschl G; Dolan DG; Lovsin Barle E
Regul Toxicol Pharmacol; 2020 Aug; 115():104692. PubMed ID: 32522580
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. 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]
11. 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]
12. 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]
13. 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]
14. 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]
15. 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]
16. 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]
17. Approaches for setting occupational exposure limits in the pharmaceutical industry.
Ahuja V; Krishnappa M
J Appl Toxicol; 2022 Jan; 42(1):154-167. PubMed ID: 34254327
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. Comparison of the acceptable surface limits derived from the skin sensitization potency for workers and swab residue limits determined from the permitted daily exposure derived from the systemic effects.
Fukushima A; Hayashi T; Takeyoshi M
J Toxicol Sci; 2023; 48(9):507-511. PubMed ID: 37661367
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]
