Original and generic drugs in the field of oral contraceptives

В. В. Каминский, М. Н. Шалько, Ю. С. Мудра

Abstract


Generics drugs are increasingly found on the pharmacies shelves today. Authors of this article have tried to find an answer to some questions: what are generic drugs and which drugs should be used – the original or generic.

Original drug is first synthesized and passed a full cycle of pre-clinical and clinical trials for drugs, it having brand name and patented chemical formula. The formula of the original drug cannot be repeated during the whole period of patent protection – 20 years. After that any pharmaceutical company can begin to release their version of this drug – there are so-called generic drugs or generics. Generic product is a drug that has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, and whose bioequivalence reference product confirmed the relevant studies of bioavailability.

Generic effectiveness is associated with its bioavailability. Rate and extent of drug accumulation at the site of its intended action are quantitative characteristic determining bioavailability of drug. Bioavailability of the drug is concluded by drug concentration in the blood. If drugs have the same bioavailability in identical conditions, they are considered bioequivalent.

The effectiveness of generic must be evaluated not only on the basis of subjective feelings of patient and doctor, but first and foremost to achieving the targets of clinical results, objectively reflecting the effect of the drug. Interchangeability is possible only for generic authenticated on the pharmacokinetic and clinical equivalence of the original drug.

The presence in manufacturer a GMP certificate (Good Manufacturing Practice for Medicinal Products), which is regularly confirmed in the course of a full-scale test production makes it a great deal of confidence to talk about the quality of drug enterprise. Only generic that manufactured in compliance with all GMP rules and past bioequivalence study should be allowed for sale and can be safely administered to a patient by doctor.


Keywords


original drug; generic; combined oral contraceptives; bioequivalence

References


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GOST Style Citations


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DOI: http://dx.doi.org/10.18370/2309-4117.2016.28.46-50

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ISSN 2411-1295 (Online), ISSN 2309-4117 (Print)