Regulatory criteria established for the acceptance of average bioequivalence do not fully satisfy the requirements arising for the interchangeability of drug products. The divergence is illustrated by noting that the regulatory criteria are compatible with large inter-individual variation of within-subject differences or ratios of the relevant kinetic parameters. Regulatory criteria of three ju...

The 2 × 2 crossover is commonly used to establish average bioequivalence of two treatments. In practice, the sample size for this design is calculated under an implicit belief that the true average bioavailabilities of the two treatments are (almost) identical. However, the ”standard” average bioequivalence analysis does not reflect this prior belief and this leads to a loss in efficiency. The ...

Bioequivalence studies are the commonly accepted methods displaying therapeutic equivalence between two products .This study was conducted to evaluate the bioequivalence between different formulations of metformin 500 mg and 1000 mg tablets which were marketed in Iran, and innovator brand. Considering that only in vitro bioequivalence studies can predict the in vivo bioequivalence, and to save ...

BACKGROUND Itraconazole is commonly used to treat systemic fungal infections in dogs, but problems exist with absorption and cost. OBJECTIVE To determine oral bioequivalence of generic and compounded itraconazole compared to original innovator (brand name) itraconazole in healthy dogs. ANIMALS Nine healthy, adult research Beagle dogs. METHODS A randomized, 3-way, 3-period, crossover desig...

Introduction: The generic drugs program provided a better population’s access to medicines. To ensure interchangeability between a brand-name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequiv...

Evaluating agreement between measurement methods or between observers is important in method comparison studies and in reliability studies. Often we are interested in whether a new method can replace an existing invasive or expensive method, or whether multiple methods or multiple observers can be used interchangeably. Ideally, interchangeability is established only if individual measurements f...

CONTEXT The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic ine...

The aim of the study was to assess the bioequivalence and tolerability of two different oral formulations of rizatriptan. A bioequivalence study was carried out in 40 healthy volunteers according to an open label, randomized, two-period, two-sequence, crossover, single dose, and fasting conditions design. The test and reference formulations were administered in two treatment days, separated by ...

Modeling and simulation methods are now commonly used in drug product development and regulatory drug review process. These applications include, but are not limited to: the development of biorelevant specifications, determination of bioequivalence matrixes for modified release products with rapid therapeutic onset, design of in vitro-in vivo correlations in a mechanistic framework, and predict...