Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE)
testing for the approval of new multisource and reformulated immediate release (IR) solid oral …

The cost of healthcare has been escalating globally during the last two decades, and this
has prompted efforts in most countries to reduce those costs. It is known that most of the …

… Midha,2 Krys J. Miller,7 Rabindra N. Patnaik,1 Norman J. … In HH Blume and KK Midha (eds.),
Bio-International … VP Shah, KK Midha, SV Dighe. Analytical methods validation …

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE)
testing for the approval of immediate release (IR) solid oral dosage forms containing …

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 …

This is a summary report of the conference on “Analytical Methods Validation: Bioavailability,
Bioequivalence and Pharmacokinetic Studies.” The conference was held from December 3 …

Addressing the need for research on the nature of refractoriness to antipsychotic drug
therapy exhibited by a substantial minority of schizophrenic patients, Philip RA May and Sven …

Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics
classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in …

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 …

Literature data are reviewed on the properties of acetaminophen (paracetamol) related to
the biopharmaceutics classification system (BCS). According to the current BCS criteria, …