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Article
Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products
This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issu...
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Chapter
Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects
This chapter provides a critical overview of the presentations and discussions of a recent workshop “Evaluation of Topical Drug Products—Current Challenges in Bioequivalence, Quality, and Novel Assessment Tech...
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Article
Bioanalytical Method Validation—A Revisit with a Decade of Progress
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Article
Pharmacokinetic evaluation of controlled release dosage forms
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Article
Bioequivalence of Topical Dermatological Dosage Forms-Methods of Evaluation of Bioequivalence
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Article
Evaluation of Orally Administered Highly Variable Drugs and Drug Formulations
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Chapter
Use of Toxicokinetic Principles in Drug Development: Bridging Preclinical and Clinical Studies
Toxicokinetics has gained wide acceptance in validating dose related drug exposure in safety evaluation studies. Although exposure is confirmed by measuring blood levels, the concept of comparing safe/toxic bl...
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Chapter
Implementation of an Effective Pharmacokinetics Research Program in Industry
Over the past decade the application of pharmacokinetic data in drug development has gradually increased. Today it is well recognized that successful drug development programs include meaningful supportive pha...
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Chapter
Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development
This report derives from the conference on “The Integration of Pharmacokinetic, Pharmacodynamic and Toxicokinetic Principles in Rational Drug Development,” held on April 24–26, 1991 in Arlington, VA. The confe...
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Chapter
Skin Metabolism
The body has several ways to protect itself from xenobiotics, and one of the major ways is by using its drug-metabolizing enzyme systems. Besides the liver, which is the major site of drug metabolism, various ...
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Article
Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development
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Article
Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies
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Article
In Vivo Percutaneous Penetration/Absorption, Washington, D.C., May 1989
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Article
In Vitro and in Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms
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Article
FDA and AAPS Report of the Workshop on Principles and Practices of In Vitro Percutaneous Penetration Studies: Relevance to Bioavailability and Bioequivalence
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Article
Report of the Workshop on Controlled-Release Dosage Forms: Issues and Controversies
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Article
Dose-Dependent Pharmacokinetics of a New Oral Cephalosporin, Cefixime, in the Dog
Cefixime (CL 284,635; FK 027) is a new third-generation oral cephalosporin. To study dose-dependent pharmacokinetics of cefixime in dogs, two balanced four-way crossover studies were conducted. In the first st...
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Article
Saturable Processes Affecting Renal Clearance of Cefixime in Dogs
The pharmacokinetics of cefixime, a new orally active cephalosporin, was studied after an intravenous dose of 50 mg/kg to four beagle dogs. Cefixime was shown to exhibit concentration dependent serum protein b...
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Article
Pharmacokinetics of bretylium in man after intravenous administration
The pharmacokinetic profile of bretylium was studied in four normal male volunteers using a new sensitive EC-GC procedure for its quantitation in biological fluids. The plasma concentrations and urinary excret.....
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Article
Protein binding of warfarin enantiomers in serum of humans and rats
The protein binding of racemic 14 C-warfarin and 3 H-S(-)-warfarin was determined in individual undiluted serum samples from 31 human subjects and 11 rats. The free fraction value of the R(+) enantiomer was dete...
