International Regulatory Approaches to Bioequivalence of Generic OIDPs. Focus On Current Regulatory Perspectives from EU, US, Canada, Brazil, China, India and Australia

      Аннотация: Asthma affects million individuals worldwide. Asthma and COPD medication market is a fast growing market, especially in the emerging markets where drugs have not been launched due to high costs. Developing Generics of OIDPs (Orally inhaled drug products) is essential, as the pricing of these medications remain a barrier to adequate patient care. OIDPs are at the forefront of asthma and COPD treatments.OIDPs should continue to remain an attractive clinical proposition. Establishing bioequivalence (BE) of an inhaled therapeutic can be a challenging proposition. Bioequivalence for oral drugs are well established. However, for inhaled drugs, there is currently no universally adopted regulatory guidance in this area has been subject to debate. Book mainly focused on regulatory approaches for approval of Generic OIDPs in the EU, US, Canada, Brazil, China, India and Australia. This book critically reviews these requirements and presents future directions for clinicians, and regulators to development and approval of Generics OIDPs. Identifying the commonalities and differences of BE recommendations provides insights & helps to set the scope for future global harmonization in Generics OIDP.

Ключевые слова: Bioequivalence, EU, Generic, guidelines, US, orally inhaled drug products