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References in periodicals archive ?
16 November 2010 - US diabetes and cancer drugs maker MannKind Corp (NASDAQ: MNKD) unveiled yesterday new data on its drug delivery, device and particle technologies demonstrating the bioequivalence, ease of use and efficiency of its novel platform.
The database currently tags 30,000 individuals working in Bioavailability / Bioequivalence.
In vitro bioequivalency data are available for several brand-name products, but the bioequivalence of generics has not been tested.
Iqbal Choudhary said that over 200 scientists and researchers from various institutions of the country will be attending the national meeting, organised by the Center for Bioequivalence Studies and Clinical Research (CBSCR) of Dr.
The company enrolled a total of 24 healthy male subjects in the single-centre, open-label, randomised, single dose cross-over Phase I trial that assessed the bioequivalence and tolerability of liquid and reconstituted lyophilised formulations of caplacizumab administered subcutaneously.
TORONTO -- Most generic formulations of antiepileptic drugs have pharmacokinetics that closely match their brand-name reference, according to an analysis of bioequivalence studies submitted to the Food and Drug Administration.
We will have a host of issues on our plate, including the continued battle over biogenerics legislation, drug safety and foreign inspections, funding for the Food and Drug Administration's office of generic drugs (OGD), state carve-out legislation, and bioequivalence.
But the agency's accepted bioequivalence range of 80%125% could put some patients at risk for breakthrough seizures or increased side effects, Dr.
The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.
for our insulin product and to receive in vivo and in vitro bioequivalence results comparing insulin produced from safflower to commercially available insulin products.
Six of the ten chapters are devoted to bioequivalence, where successful studies are required for regulatory approval.
Editorial will include "basic knowledge" about bioequivalence and therapeutic equivalence of generics and will allow readers to counsel their patients about generic prescriptions.