Regulatory considerations for in vitro/in vivo correlations

American Pharmaceutical Review

Volumn 8, Issue 5, 2005, Pages 42-45

  Uppoor, Ramana S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISSOLUTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW;

EID: 33749322196     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. FDA, September 1997, Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations.
2. FDA, September 1997, Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation.