A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing – Operational considerations

A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guideline centers around the use of the Acceptable Daily Exposure (ADE) [synonymous with the Permitted Daily Exp...

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Veröffentlicht in:	Regulatory toxicology and pharmacology 2016-08, Vol.79, p.S39-S47
Hauptverfasser:	Hayes, Eileen P., Jolly, Robert A., Faria, Ellen C., Barle, Ester Lovsin, Bercu, Joel P., Molnar, Lance R., Naumann, Bruce D., Olson, Michael J., Pecquet, Alison M., Sandhu, Reena, Shipp, Bryan K., Sussman, Robert G., Weideman, Patricia A.
Format:	Artikel
Sprache:	eng
Schlagworte:	Acceptable Daily Exposure (ADE) Active Pharmaceutical Ingredient (API) Animals Cross-contamination Dedicated/segregated facilities Dose-Response Relationship, Drug Drug Industry - legislation & jurisprudence Drug Industry - standards Guidelines as Topic Health Policy Humans International Society of Pharmaceutical Engineers (ISPE) Maximum allowable carryover (MAC) or maximum safe carryover (MSC) Maximum Daily Dose (MDD) No-Observed-Adverse-Effect Level Occupational Exposure - adverse effects Occupational Exposure - legislation & jurisprudence Occupational Exposure - prevention & control Occupational Exposure - standards Occupational Health - legislation & jurisprudence Occupational Health - standards Permitted Daily Exposure (PDE) Pharmaceutical Preparations - classification Pharmaceutical Preparations - standards Policy Making Process intermediates (PI) Risk Assessment Starting materials (SM) Threshold of Toxicological Concern (TTC) Toxicity Tests
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