The role of in vitro-in vivo correlations (IVIVC) to regulatory agencies.
Malinowski
H J
HJ
Director Division of Pharmaceutical Evaluation I, Food and Drug Administration, Rockville, Maryland 20852, USA.
D000082:Acetaminophen / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000592:standards; D000284:Administration, Oral; D003975:Diazepam / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000592:standards; D005060:Europe; D006801:Humans; D006863:Hydrogen-Ion Concentration; D066298:In Vitro Techniques; D007408:Intestinal Absorption; D007564:Japan; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000592:standards*; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations; D000082:Acetaminophen; D003975:Diazepam