BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

293 related articles for article (PubMed ID: 27233924)

  • 1. 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]  

  • 2. 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]  

  • 3. 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]  

  • 4. 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]  

  • 5. 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]  

  • 6. A harmonization effort for acceptable daily exposure derivation - Considerations for application of adjustment factors.
    Sussman RG; Naumann BD; Pfister T; Sehner C; Seaman C; Weideman PA
    Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S57-66. PubMed ID: 27221789
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. 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]  

  • 9. Toxicokinetic and toxicodynamic considerations when deriving health-based exposure limits for pharmaceuticals.
    Reichard JF; Maier MA; Naumann BD; Pecquet AM; Pfister T; Sandhu R; Sargent EV; Streeter AJ; Weideman PA
    Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S67-78. PubMed ID: 27224509
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Harmonization efforts for deriving health-based exposure limits in the pharmaceutical industry - Advancing the current science and practice.
    Weideman PA; Pecquet AM; Maier MA
    Regul Toxicol Pharmacol; 2016 Aug; 79 Suppl 1():S1-2. PubMed ID: 27531049
    [No Abstract]   [Full Text] [Related]  

  • 11. 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]  

  • 12. 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]  

  • 13. 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]  

  • 14. 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]  

  • 15. A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing systems.
    Jenke D; Carlson T
    PDA J Pharm Sci Technol; 2014; 68(5):407-55. PubMed ID: 25336416
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. 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]  

  • 18. 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]  

  • 19. Considerations regarding a permitted daily exposure calculation for ethyl methanesulfonate.
    Müller L; Gocke E
    Toxicol Lett; 2009 Nov; 190(3):330-2. PubMed ID: 19857798
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Setting occupational exposure limits for pharmaceuticals.
    Naumann BD; Sargent EV
    Occup Med; 1997; 12(1):67-80. PubMed ID: 9153053
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 15.