• Publications
  • Influence
Bioanalytical Method Validation—A Revisit with a Decade of Progress
This report is a synthesis of (1) the earlier conference on Analytical Methods Validation−Bioavailability, Bioequivalence and Pharmacokinetic Studies (Conference held in Arlington, VA, December 3–5,Expand
  • 1,532
  • 53
Molecular properties of WHO essential drugs and provisional biopharmaceutical classification.
The purpose of this study is to provisionally classify, based on the Biopharmaceutics Classification System (BCS), drugs in immediate-release dosage forms that appear on the World Health OrganizationExpand
  • 694
  • 45
Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies
TLDR
This is a summary report of the conference on "Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies." The conference was held from December 3 to 5,1990, in the Washington, D.C., area. Expand
  • 517
  • 34
How to achieve international action on falsified and substandard medicines
Substandard and falsified medicines kill patients, yet progress on the twin challenges of safeguarding the quality of genuine medicine and criminalising falsified ones has been held back byExpand
  • 128
  • 12
  • PDF
Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium.
Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage formsExpand
  • 124
  • 10
  • PDF
An Approach for Widening the Bioequivalence Acceptance Limits in the Case of Highly Variable Drugs
AbstractPurpose. Highly variable drugs pose a problem in bioequivalence assessment because they often fail to meet current regulatory acceptance criteria for average bioequivalence (80–125%). ThisExpand
  • 69
  • 9
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Abstract This is a summary report of the conference on “Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies.” The conference was held from December 3 to 5,1990,Expand
  • 958
  • 8
Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and
Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data onExpand
  • 143
  • 8
  • PDF
Enantioselective pharmacokinetics and pharmacodynamics of dl‐thero‐mcthylphenidate in children with attention deficit hyperactivity disorder
Nine boys with attention‐deficit hyperactivity disorder took part in a study in which d‐methylphenidate, l‐methylphenidate, dl‐methylphenidate, or placebo were administered in a double‐blind,Expand
  • 120
  • 8
Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies
Abstract This is a summary report of the conference on ‘Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies.’ The conference was held from December 3 to 5,Expand
  • 181
  • 7