Share This Author
Bioanalytical Method Validation—A Revisit with a Decade of Progress
The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop.
Molecular properties of WHO essential drugs and provisional biopharmaceutical classification.
The results suggest that a satisfactory bioequivalence (BE) test for more than 55% of the high-solubility Class 1 and Class 3 drug products on the WHO Essential Drug List may be based on an in vitro dissolution test.
Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies
Assessment of the major agreements and issues discussed at the conference on analytical methods validation are represented to provide guiding principles for validation of analytical methods employed in bioavailability, bioequivalence and pharmacokinetic studies in man and animals.
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 forms…
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 on…
Enantioselective pharmacokinetics and pharmacodynamics of dl‐thero‐mcthylphenidate in children with attention deficit hyperactivity disorder
- N. Srinivas, J. Hubbard, D. Quinn, K. Midha
- Medicine, ChemistryClinical pharmacology and therapeutics
- 1 November 1992
The computer tests revealed a drug‐induced improvement in sustained attention that was entirely attributable to the d‐enantiomer, and there was no evidence to suggest that the effectiveness of d‐methylphenidate was in any way compromised by the presence of its antipode.
In vitro characterization of the metabolism of haloperidol using recombinant cytochrome p450 enzymes and human liver microsomes.
- J. Fang, G. Mckay, J. Song, A. Remillrd, X. Li, K. Midha
- Biology, ChemistryDrug metabolism and disposition: the biological…
- 1 December 2001
Interestingly, it was found that recombinant CYP1A1 has the highest activity for oxidizing RHP(+) to HP(+), which suggests a prominent role for CYP3A4 in the metabolism of HAL.
Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen.
A biowaiver for immediate release (IR) ibuprofen solid oral drug products is scientifically justified, provided that the test product contains only those excipients reported in this paper in their usual amounts.
An Approach for Widening the Bioequivalence Acceptance Limits in the Case of Highly Variable Drugs
- A. Boddy, F. Snikeris, R. Kringle, G. Wei, J. Oppermann, K. Midha
- SociologyPharmaceutical Research
- 1 December 1995
This paper challenges the “one size fits all” current definition of bioequivalence acceptance limits for highly variable drugs, proposing alternative limits or “goal posts” which vary in accordance with the intrasubject variability of the reference product.
Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol).
It is concluded that differences in rate of absorption were considered therapeutically not relevant by the Health Authorities and in vitro dissolution data collected according to the relevant Guidances can be safely used for declaring bioequivalence (BE) of two acetaminophen formulations.