01 January 2008
Generic products – requirements for drug registration
P. K. KunickiAnn Transplant 2008; 13(1): 30-30 :: ID: 880184
Abstract
European Regulatory Agencies e.g. EMEA define what generic product is. It is a medicinal product essentially similar to an original product i.e. which has the same qualitative and quantitative composition in active substances, the same pharmaceutical form, and whose bioequivalence with the reference product has been demonstrated by appropriate bioavailability studies. It means that generic should be almost identical to an innovator product and everyone knows it is almost impossible. Therefore, precise quantitative criteria are necessary to set the borderline for dissimilarity that could be accepted regarding drug safety and efficacy. The majority of generics of generally acting drugs require for registration purposes bioequivalence studies thus this is statistical acceptance for bioavailability parameters what creates the door onto a market. The simplest study design is: single dose, 2-period, 2-sequence, crossover bioequivalence study in young (18-55 y.) healthy volunteers in fasting state, if necessary the design becomes more complex including food effect testing and multiple dosing. In general, Registration Agencies require for proving average bioequivalence, 90% confidence intervals for AUC and Cmax ratios (test/reference) within 0.80-1.25 for log-transformed data. That means generic product is acceptable differing up to 20% from the reference product in 90% of subjects. That door seems to be too wide for a few percent of drugs which are "narrow therapeutic index" and/or "critical dose" drugs. It is obvious that because of clear economic reasons, the manufacturer introducing generic drug is doing only what is necessary for successful registration of the product i.e. the simplest, the shortest and the cheapest study. Such a situation may provoke the collision of interest between patient's safety and interest of generic companies. Therefore the task for Registration Agencies is to create and to obey clear rules for introducing generic products on the market taking into account that bioequivalence requirements must be related to specifi c drug.
Keywords: intellectual disability (mental retardation), Metabolism syndrome, Transplantation
In Press
07 Mar 2024 : Original article
Outcomes of Renal Transplantation in ANCA-Associated VasculitisAnn Transplant In Press; DOI: 10.12659/AOT.943433
08 Mar 2024 : Original article
Association of Coronary Calcium Score on Cardiac PET During Pre-Kidney Transplant Assessment with Persisten...Ann Transplant In Press; DOI: 10.12659/AOT.943532
14 Mar 2024 : Original article
Impact of Blood Products Transfusion on Patients in the Immediate Post-Lung Transplant Period: A Cohort StudyAnn Transplant In Press; DOI: 10.12659/AOT.943652
14 Mar 2024 : Case report
Treatment of Cavernous Transformation of Portal Vein Caused by Hepatic Cystic Echinococcosis Using Ex Vivo ...Ann Transplant In Press; DOI: 10.12659/AOT.942358
Most Viewed Current Articles
05 Apr 2022 : Original article
Impact of Statins on Hepatocellular Carcinoma Recurrence After Living-Donor Liver TransplantationDOI :10.12659/AOT.935604
Ann Transplant 2022; 27:e935604
12 Jan 2022 : Original article
Risk Factors for Developing BK Virus-Associated Nephropathy: A Single-Center Retrospective Cohort Study of ...DOI :10.12659/AOT.934738
Ann Transplant 2022; 27:e934738
22 Nov 2022 : Original article
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipient...DOI :10.12659/AOT.937988
Ann Transplant 2022; 27:e937988
15 Mar 2022 : Case report
Combined Liver, Pancreas-Duodenum, and Kidney Transplantation for Patients with Hepatitis B Cirrhosis, Urem...DOI :10.12659/AOT.935860
Ann Transplant 2022; 27:e935860