Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products?

Journal of Pharmacy and Pharmaceutical Sciences

Volumn 13, Issue 1, 2010, Pages 107-113

  Endrenyi, Laszlo ^a   Tothfalusi, Laszlo ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

ADALAT XL; METHYLPHENIDATE; NIFEDIPINE; UNCLASSIFIED DRUG; CALCIUM CHANNEL BLOCKING AGENT; CENTRAL STIMULANT AGENT;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CONTROLLED STUDY; DISCRIMINANT ANALYSIS; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DELIVERY SYSTEM; DRUG DETERMINATION; DRUG FORMULATION; DRUG RELEASE; HUMAN; MAXIMUM PLASMA CONCENTRATION; REVIEW; SUSTAINED DRUG RELEASE; ARTICLE; DELAYED RELEASE FORMULATION; DRUG CONTROL; PHARMACOKINETICS;

AREA UNDER CURVE; CALCIUM CHANNEL BLOCKERS; CENTRAL NERVOUS SYSTEM STIMULANTS; DELAYED-ACTION PREPARATIONS; DRUG AND NARCOTIC CONTROL; HUMANS; METHYLPHENIDATE; NIFEDIPINE; THERAPEUTIC EQUIVALENCY;

EID: 77955474116     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: 10.18433/J32G6P     Document Type: Review

References (23)

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