High variability in drug pharmacokinetics complicates determination of bioequivalence: experience with verapamil

scientific article published on 01 June 1996

High variability in drug pharmacokinetics complicates determination of bioequivalence: experience with verapamil is …
instance of (P31):
scholarly articleQ13442814

External links are
P356DOI10.1023/A:1016040825844
P698PubMed publication ID8792420

P2093author name stringP Gordon
R Pop
M Spino
Y C Tsang
J Hems
P2860cites workReview of methods and criteria for the evaluation of bioequivalence studiesQ37917202
The metabolism of DL-[14C]verapamil in manQ39263239
Sample size determination for bioequivalence assessment using a multiplicative modelQ47406463
Logarithmic transformation in bioequivalence: application with two formulations of perphenazine.Q52401473
An approach for widening the bioequivalence acceptance limits in the case of highly variable drugsQ71485694
P433issue6
P921main subjectpharmacokineticsQ323936
verapamilQ410291
P304page(s)846-850
P577publication date1996-06-01
P1433published inPharmaceutical ResearchQ7180737
P1476titleHigh variability in drug pharmacokinetics complicates determination of bioequivalence: experience with verapamil
P478volume13

Reverse relations

cites work (P2860)
Q43620208A validated method for the determination of verapamil and norverapamil in human plasma
Q41820962Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds
Q38383015Biopharmaceutical considerations and characterizations in development of colon targeted dosage forms for inflammatory bowel disease
Q47913024Clinical pharmacokinetics of vasodilators. Part I.
Q37611789Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence
Q36331533Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
Q24804024Individualizing therapy - in search of approaches to maximize the benefit of drug treatment (II)
Q34146073Metabolite parameters as an appropriate alternative approach for assessment of bioequivalence of two verapamil formulations
Q28200162Pharmacokinetics of ethionamide administered under fasting conditions or with orange juice, food, or antacids
Q34476718Understanding the scientific issues embedded in the generic drug approval process.
Q35826959Within- and between- subject variability in methadone pharmacokinetics and pharmacodynamics in methadone maintenance subjects

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