Journal of Bioequivalence & Bioavailability

Impact of OMICS technologies in BA/BE study

4^th World Congress on Bioavailability and Bioequivalence: Pharmaceutical R&D Summit

May 20-22, 2013 DoubleTree by Hilton, Beijing, China

Pradip K Mazumder

AcceptedAbstracts: J Bioequiv Availab

Abstract:

The neologism omics informally refers to a field of study in biology ending in-omics, such as genomics, proteomics or metabolomics. The related suffix -ome is used to address the objects of study of such fields, such as the genome, proteome or metabolome respectively. The approval process of a generic drug entails the assessment of bioequivalence in drug absorption which is usually considered as a surrogate for evaluation of drug efficacy and safety in clinical studies. For some generic drug products, the United States Food and Drug Administration indicates that the assessment of similarity between dissolution profiles may be used as a surrogate for assessment of bioequivalence (1). The nuances of regulatory process for marketing authorization of biosimilars is currently under progress in certain countries. In the EU, EMEA has clearly defined the process including overarching and product-specific guidelines, which includes clinical testing. The evaluation of Biosimilar products need to be based on comparability criteria, including at least molecular characterization, biological activity relevant for the therapeutic effect and relative bioavailability ("bioequivalence"). Disruptive technologies like Genomic Microarrays assays might be useful to compare biopharmaceuticals obtained from multiple sources (2). Impact of enabling OMICS technologies in BA/BE study is discussed. References cited are duly acknowledged in discussion