Challenges and solutions to metabolites in safety testing: Impact of the International Conference on Harmonization M3(R2) guidance

Expert Opinion on Drug Metabolism and Toxicology

Volumn 6, Issue 12, 2010, Pages 1539-1549

  Yu, Hongbin ^a   Bischoff, Daniel ^b   Tweedie, Donald ^a  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Bioanalytical quantiation; Disproportionate drug metabolite; ICH M3(R2); MIST; Relevant metabolites; Safety testing of drug metabolites

Indexed keywords

DRUG METABOLITE;

CLINICAL DEVELOPMENT PLAN; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG INDUSTRY; DRUG METABOLISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; IN VIVO STUDY; RADIATION DETECTION; RADIOACTIVITY; REVIEW; STEADY STATE; WHOLE BODY AUTORADIOGRAPHY;

ANIMALS; AREA UNDER CURVE; DRUG DESIGN; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; INTERNATIONAL AGENCIES; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78649231563     PISSN: 17425255     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425255.2010.530655     Document Type: Review

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