Clinical studies: generic medicines

Abstract

Clinical testing is not the only way to discover drug effects on people. That is the reason controlled clinical trials are the only legal basis for central regulatory agencies in each country, such as FDA, to conclude that a new drug has clinical effectiveness for a drug or biologic. Before clinical testing begins, researchers analyze the drug's main physical and chemical properties in the laboratory and study its pharmacological and toxic effects in laboratory animals. On the other hand, bioequivalence studies are the clinical test used, most often, when a sponsor proposes manufacture a generic version of an approved off-patent product. The law 9.787 (1999), established the legal basis for the institution of generic drugs in Brazil. Our research group started clinical trial and bioequivalence studies, with collaboration of the Public Pharmaceutical Laboratory of Pernambuco State (LAFEPE), the Brazilian official company to pioneer the development of medicines for AIDS and herperviruses treatment, between 1995 to 1998, even before the establishment of generic policy in Brazil. In 1997 and 1998, LAFEPE was ranked in 21 st market position vs. all public and private pharmaceutical laboratories in Brazil. The Aids medicines at a low cost increased the production and sales, and were the main reason of such inedited result.As a result of the studies developed, the following medicines were introduced to the Brazilian market by LAFEPE: stavudine and zidovudine (AZT) capsules, ganciclovir injectable, lamivudine + AZT, didanosine, lamivudine, and zalcitabine tablets. The result showed bioequivalence for lamivudine tablets (RT) as the 90% CI for both Cmax (99,7) and AUC0-12 (96,7) geom. mean ratios lie within the 80-125% interval. On AZT + DDI therapy the plasma HIV RNA levels decreased > 0, 5 log after 30 days. The ganciclovir clinical study showed similar results in reference product by the control of retinitis in Aids patients infected with CMV. The stavudine and zalcitabine clinical study demonstrated no adverse effects reported and biochemical parameters remained unchanged and within the reference range. The pharmacokinetics parameters found for AZT + Lamivudine tablet were: AUC0-12 (8975 e 12.189ng.h/ml); Cmax (7.330 e 3.610 ng/ml) respectively, similar to the reference medicine. - ( May 24, 2002 ) . * E-mail: leac@nlink.com.br BACTERIOLOGICAL LARVICIDES OF DIPTERAN DIS-EASE VECTORS Maria Helena N. L. Silva-FilhaCentro de Pesquisas Aggeu Magalhães -FIOCRUZ, 50670-420 Recife, PE. Presented by Helio B. CoutinhoThe bacteria Bacillus sphaericus (Bs) and B. thuringiensis serovar. israelensis (Bti), display toxic action on mosquitoes and black flies, important vectors of man disease, acting as per os larvicides. These sporulating bacteria show a major advantage over synthetic insecticides: selectivity due to the specific mode of action. Bs is toxic against some species of Culicidae while Bti is also highly toxic against Simuliidae.Both bacteria produce, during the sporulation, crystals, which contain protoxins. Bti crystal...

Health Innovation and Social Justice in Brazil

“…A noteworthy article published by the University of Recife Bio-equivalence centre, in May 2002, in the Anais da Academia Brasileira de Ciências (Annals of the Brazilian Academy of Sciences), traced bio-equivalence testing on similar drugs in Brazil back to 1995: "our research group started clinical trials and bioequivalence studies, with the collaboration of the public pharmaceutical laboratory of Pernambuco State (LAFEPE), the Brazilian official company to pioneer the development of medicines for AIDS and herpes virus treatment, between 1995 and 1998, even before the establishment of generic policy in Brazil" 31 . The article then gave the results of bio-equivalence for AZT, Ganiclovir, didanosine, lamivudine and zalcitabine, and for a LAFEPE fixed-dose combination "similar to the reference medicine".…”