Abstract
Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.
Highlights
Medicines are the most important tool that society possesses to prevent, alleviate and cure diseases (Leach, Palluzi, Munderi, 2005)
The Biopharmaceutics Classification System (BCS) developed by Amidon et al (1995) aimed to employ specific tests in vitro in order to predict the drugs dissolution and to estimate the results of their bioavailability (BD) in vivo, produced a significant impact on drug policy, making it possible to exempt BD and BE tests in vivo for class I drugs in oral solid dosage forms (FDA, EMA, Agência Nacional de Vigilância Sanitária (ANVISA) and World Health Organization (WHO)) for class III (EMA and WHO) and for a specific group of class II compounds (WHO)
One of the current applications of BCS is to supply means to provide biowaiver of new generic medicines containing drugs belonging to classified as highly soluble and highly permeable (Class I) (FDA, EMA, WHO and ANVISA), class III (EMA and WHO) and a specific group of compounds of class II (WHO)
Summary
Medicines are the most important tool that society possesses to prevent, alleviate and cure diseases (Leach, Palluzi, Munderi, 2005). About 30% of the world population has no access to effective, safe and quality medicines,and more than half of those live in developing countries in Africa and Asia (WHO, 2004).This problem is so serious that in 2000 the United Nations (UN), analyzing the major problems of the world, established the Millennium Program, where 191 countries signed an agreement with 8 goals and 18 targets that must be achieved until 2015. Several factors influence people’s access to medicines and it is necessary a national policy to regulate and monitor these several factors Among those we may cite: a system for efficient drug selection and free from pressures, a policy of public funded sustainable system for regulating the drug market, controlling overtaxes and other factors that impact on prices, as well as an efficient distribution system (Leach, Palluzi, Munderi, 2005).
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