Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for short-term clinical trials

Regulatory Toxicology and Pharmacology

Volumn 65, Issue 1, 2013, Pages 162-167

  Bercu, Joel P ^a   Dolan, David G ^a  

^a AMGEN INC   (United States)

Author keywords

ADE; Cleaning; Clinical; Drug; Manufacturing; MRTD; Pharmaceutical; Subchronic; Substance; TTC

Indexed keywords

ARTICLE; CHRONIC TOXICITY; CLINICAL STUDY; CONTROLLED STUDY; DATA ANALYSIS; DEVELOPMENTAL TOXICITY; DRUG CONTROL; DRUG EXPOSURE; DRUG MANUFACTURE; DRUG POTENCY; DRUG TOXICITY; HUMAN; MEDICAL SOCIETY; PRIORITY JOURNAL; PROCESS DEVELOPMENT; REPRODUCTIVE TOXICITY; VALIDATION PROCESS;

CLINICAL TRIALS, PHASE I AS TOPIC; DATABASES, FACTUAL; DRUG CONTAMINATION; DRUG DESIGN; DRUG INDUSTRY; EQUIPMENT CONTAMINATION; HUMANS; INTERNATIONAL AGENCIES; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; TOXICOLOGY;

EID: 84871777826     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.06.012     Document Type: Article

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