# \[e-drug\] Generic quality (cont) **URL:** https://talk.edrugplus.org/t/e-drug-generic-quality-cont/10467 **Category:** e-drug **Created:** [February 23, 2001, 9:52am UTC](https://talk.edrugplus.org/t/e-drug-generic-quality-cont/10467 "2001-02-23T09:52:31Z") **Posts on this page:** 1 **Page:** 1
### Author: ![Jody\_Dalmacion](https://avatars.discourse-cdn.com/v4/letter/j/9dc877/32.png) [@Jody\_Dalmacion](https://talk.edrugplus.org/u/Jody_Dalmacion) #### Post date: [February 23, 2001, 9:52am UTC](https://talk.edrugplus.org/t/e-drug-generic-quality-cont/10467/1 "2001-02-23T09:52:31Z")
E-drug: Generic quality (cont) --------------------------------------------- Dear Dr. Smith, In the Philippines, we used to require bioequivalence testing for generic products that fall under what we call List B which means that these are drugs that have narrow margin of safety, may pose bioavailability problems because it is easily affected by factors like age, food etc and for other similar reasons. Our regulatory agency created an advisory board to decide on the accreditation of institutions or agencies that wish to conduct bioavailability test. However, there is no standard lab that can validate their results. This is a problem which I think, developed countries can help us. When I did my bioequivalence studies for three rifampicin formulations 2 years ago, I obtained results showing that the 3 formulations were not bioequivalent. I deliberately set aside aliquots of my blood samples, unfortunately several months passed with me unable to solicit help to help me validate my results. So I guess it is for me to simply claim that my results are valid and reliable and be challenged. The Department of Pharmacology of UP College of Medicine had performed several bioequivalence studies dating as far back 15 years ago.Please be informed that more often than not our generic products were bioequivalent with the originator drug or the drug dominating the market. In fact, to our surprise, we discovered two generic products from two multinationals failing the test. So it is not true that generics from developed countries always pass bioavailability test. I have replied to your message because as the chair of the Department I am looking for agencies, institutions or anybody who can serve as our standard or reference lab. I hope you can help us. Jody Vergeire-Dalmacion,MD Department of Pharmacology and Toxicology UP College of Medicine 547 Pedro Gil, Ermita 1000 Manila Philippines email:jund45@hotmail.com -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.