Novel approach to bioequivalence assessment based on physiologically motivated model

The study was conducted to exemplify an approach capable of obtaining a new insight into bioequivalence (BE) assessment, by the use of a physiologically motivated model. Data from an oral BE study of two piroxicam (PXM) products was used as an example. The BE study was carried out with 24 healthy Eu...

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Bibliographic Details
Published in:International journal of pharmaceutics 2009-10, Vol.380 (1), p.89-95
Main Authors: Tvrdonova, Martina, Chrenova, Jana, Rausova, Zuzana, Miklovicova, Daniela, Durisova, Maria, Mircioiu, Constantin, Dedik, Ladislav
Format: Article
Language:English
Subjects:
Adolescent
Adult
Anti-Inflammatory Agents, Non-Steroidal - blood
Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics
Bioavailability
Biological and medical sciences
Cross-Over Studies
Delayed gastric emptying
Drugs, Generic - pharmacokinetics
Entero-hepatic cycling
General pharmacology
Generic drug
Humans
Male
Medical sciences
Middle Aged
Models, Biological
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Piroxicam - blood
Piroxicam - pharmacokinetics
Simulation
Therapeutic Equivalency
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Summary:The study was conducted to exemplify an approach capable of obtaining a new insight into bioequivalence (BE) assessment, by the use of a physiologically motivated model. Data from an oral BE study of two piroxicam (PXM) products was used as an example. The BE study was carried out with 24 healthy European subjects according to a two-sequence crossover-randomized design. The test and reference formulations were a PXM generic formulation (LaborMed Pharma, Romania) and Feldene ® (Pfizer, USA), respectively. Plasma concentrations of PXM were monitored by a validated high-performance liquid chromatography over a period of 144 h after administration. After the structure of the optimal model was selected, parameters that characterized the whole-body disposition behavior of PXM in the subjects were derived. The paired Student's t-test and Wilkoxon's test were performed on the derived parameters. The null hypothesis of no differences in the parameters of the whole-body disposition behavior of PXM related to the test and reference product was not rejected at 5% level of significance. This result suggested that the compared products were bioequivalent and could be used interchangeably in clinical setting. The presented approach might show a new way, worth incorporating in future BE guidelines.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2009.07.004