Reach Us +1-217-403-9671
Evaluation Of Bioequivalence Of Generic Drugs: The Mexican Experience | 8265
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Evaluation of bioequivalence of generic drugs: The Mexican experience

2nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

Francisco J. Flores-Murrieta

Special Issue BABE-2011: Posters: JBB

DOI: 10.4172/0975-0851.1000105

R egulatory changes established in Mexico in 1998 made mandatory evaluation of interchangeability of generic drugs, by comparison of dissolution profi le or demonstration of bioequivalence. Since then, a lot of studies of bioequivalence have been conducted in Mexico. Several important aspects have been observed during the conduction of such studies. On one hand, it has been observed that most of the cases in which bioequivalence was not concluded was in drugs that are classifi ed as type IV according their solubility and permeability, whereas, bioequivalence was concluded in drugs classifi ed as type I and III (high solubility) although diff erences in dissolution profi le was observed and, moreover, in diff erent pharmaceutical formulations, i.e. capsule against tablet. On the other hand, when pharmacokinetic parameters obtained in these studies were compared with the values reported in other populations, it has been observed that increased levels are reached in Mexicans in comparison with those reported in Caucasians for drugs metabolized by CYP3A4 and for drugs that are substrates of p-glycoprotein. Such diff erences were refl ected in a higher incidence of side eff ects and suggest interethnic diff erences in the pharmacokinetics of this kind of drugs. According to these results, it is mandatory to re-evaluate dosage regimes used in Mexico according to our population characteristics
Francisco Javier Flores-Murrieta has completed his Ph.D in 1991 from Centro de Investigaci?n y de Estudios Avanzados del Instituto Polit?cnico Nacional. Currently, he is the head of the Unit of Pharmacology Research of the Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas and Professor of Escuela Superior de Medicina del Instituto Polit?cnico Nacional. He has published more than 100 papers in reputed journals on Pharmacokinetics (preclinical and clinical), analytical methods and analgesia, 5 book chapters and 1 book. He has supervised more than 30 posgrade thesis. He has received several awards in Mexico, including ?Honors of the National Youth Award? and the ?Mexican Academy of Sciences Award?. He served as president of the Western Pharmacology Society and the Mexican Pharmacology Association and currently he is Fellow of the American College of Clinical Pharmacology and member of the editorial board of Pharmacology and Pharmacy, The Open Clinical Trials Journal and The Proceedings of the Western Pharmacology Society