Biological medical products are drugs whose active components are produced only by living, genetically modified organisms or live cell cultures. Patents and exclusivity for most biopharmaceuticals has either expired or will expire soon, which enables biotechnological companies to introduce similar biological products. The problem of replacing a biological medicine with a biosimilar in the cours...

The introduction of cyclosporine (CsA) in clinical practice has significantly improved patient and allograft survival after organ transplantation. The new microemulsion CsA formulation, Neoral, has been associated with a more reproducible absorption and a better patient outcome as compared to the old formulation Sandimmune. Recently, several generic CsA formulations have been tested as bioequiv...

No bioequivalence studies have been conducted for mesalamine because of differences in formulation. Based on U.S. Food and Drug Administration definitions for bioequivalence, none of these drugs can be classified as bioequivalent or therapeutically equivalent. No adequate comparative trials have been conducted with equivalent mesalamine doses to determine if any of the current formulations are ...

The Food and Drug Administration requires rigorous testing of generic formulations of antiepileptic drugs to assure bioequivalence to the brand product and asserts that all approved formulations are interchangeable. Physician surveys, case reports, and "switchback" rates from large-scale generic conversions imply that all generic formulations may not be equal to the brand drug for all patient g...

Advances in predicting in vivo performance of drug products has the potential to change how drug products are developed and reviewed. Modeling and simulation methods are now more commonly used in drug product development and regulatory drug review. These applications include, but are not limited to: the development of biorelevant specifications, the determination of bioequivalence metrics for m...

I. INTRODUCTION When the drug can be absorbed by the blood system, the bioequivalence of a generic drug is evaluated with a crossover design based on pharmacokinetic endpoints. However, for treatment of non-systemic symptoms, bioequivalence evaluation is regularly designed as a randomized clinical trial with three parallel treatment groups – T, the test treatment group, R, the reference treatme...

In the current EMA guidance it is stated that in principle, evaluation of bioequivalence should be based upon measured concentrations of the parent compound (also for inactive pro-drugs) as the Cmax of the parent compound is usually more sensitive to detect differences in absorption rate than the Cmax of the metabolite. Only for some pro-drugs with very low plasma concentrations and quickly eli...

Introduction: Approval of generic drugs requires only bioequivalence studies. Some research suggests that vancomycin is not clinically equivalent to the branded drug, and this exposes patients therapeutic failure development microbial resistance.
 Aims: Compare rates microbiological clinical between Vancocin-CP®.
 Methods: Retrospective cohort analysis hospitalized adults with culture...