297 related articles for article (PubMed ID: 31420508)
1. 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]
2. 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]
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. 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]
5. Scale-Up Procedure for Primary Drying Process in Lyophilizer by Using the Vial Heat Transfer and the Drying Resistance.
Kawasaki H; Shimanouchi T; Yamamoto M; Takahashi K; Kimura Y
Chem Pharm Bull (Tokyo); 2018; 66(11):1048-1056. PubMed ID: 30381657
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. 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]
8. Cleaning verification: A five parameter study of a Total Organic Carbon method development and validation for the cleaning assessment of residual detergents in manufacturing equipment.
Li X; Ahmad IAH; Tam J; Wang Y; Dao G; Blasko A
J Pharm Biomed Anal; 2018 Feb; 149():33-39. PubMed ID: 29100028
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. Application of surface-enhanced Raman spectroscopy (SERS) for cleaning verification in pharmaceutical manufacture.
Corrigan DK; Cauchi M; Piletsky S; Mccrossen S
PDA J Pharm Sci Technol; 2009; 63(6):568-74. PubMed ID: 20169863
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. 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]
13. 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]
14. 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]
15. 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]
16. 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]
17. 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]
18. The need for new control strategies for particulate matter in parenterals.
Poms J; Sacher S; Nixdorf M; Dekner M; Wallner-Mang S; Janssen I; Khinast JG; Schennach R
Pharm Dev Technol; 2019 Jul; 24(6):739-750. PubMed ID: 30821571
[TBL] [Abstract][Full Text] [Related]
19. Multicomponent cleaning verification of stainless steel surfaces for the removal of dairy residues using infrared microspectroscopy.
Lang MP; Kocaoglu-Vurma NA; Harper WJ; Rodriguez-Saona LE
J Food Sci; 2011 Mar; 76(2):C303-8. PubMed ID: 21535750
[TBL] [Abstract][Full Text] [Related]
20. Lyophilization of Small-Molecule Injectables: an Industry Perspective on Formulation Development, Process Optimization, Scale-Up Challenges, and Drug Product Quality Attributes.
Butreddy A; Dudhipala N; Janga KY; Gaddam RP
AAPS PharmSciTech; 2020 Sep; 21(7):252. PubMed ID: 32885357
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
