IBI Factor 3.9
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Quarterly published in print and online "Inventi Rapid: Biosimilars & Biopharmaceuticals (Formerly Inventi Rapid: Biosimilars)" publishes high quality unpublished as well as high impact pre-published research and reviews catering to the needs of researchers and professionals. This journal focuses on manufacture, development and usage of biopharmaceutical compounds considered similar to an innovator agent. The topics included are chemical composition and structure, quality and purity, patent issues, bioequivalence and interchangeability, clinical efficacy data, economic considerations etc.
The PMDA has some stringent data requirements, which make Japan unique. Japan’s regulatory environment is significantly more complicated than any other country. The level of accuracy and details required by the Japanese regulatory authority is sometimes even greater than the US FDA (the United States Food and Drug Administration), the EMA (the European Medicine Agency) or any other pharmaceutical regulatory agency. Japan's Pharmaceutical market is one of the largest markets in the world and the market value is about $95 billion as per the data of the ministry of Health, Labour and Welfare (MHLW). This market is expected to expand at a CAGR of 1.06% from 2022 to 2027. In Japan the PMDA office of biologicals provide consultations concerning clinical trials of new biologic drugs and handle biotechnology medicines, which include biosimilar and biological products. The purpose of this review article is to provide a basic understanding of legal regulatory systems, marketing authorization application, the Pharmaceutical and Medical Device Agency (PMDA) review process, timing requirements in Japan, with a focus on biological drug products for human use....
Erythropoietin is a glycoprotein hormone that stimulates production of red blood cells in the body and is significant for chronic kidney patients associated anemia. It is thus important to assess the efficacy and safety of this product before its entry into the market. In the present study Quality Control testing of recombinant human Erythropoietin (rhEPO) was carried out as per the procedures and specifications laid down in Indian Pharmacopoeia (IP, 2018). In-vivo bioassay for potency estimation was done for Erythropoietin Injection by measurement of stimulation of reticulocyte production in normocythaemic mice using reticulocyte counting by flow cytometry. The biological activity of 54 different batches of rhEPO was compared with that of Erythropoietin Reference Standard and was expressed in International Units (IU). The results of potency estimation obtained at our laboratory at National Institute of Biologicals (NIB) were also compared with manufacturers result as per their Certificate of Analysis (COA) for 20 out of 54 batches of rhEPO and were found to be within the limits prescribed and difference was not statistically significant when plotted on QC Chart. Thus, the present study demonstrates that the potency estimation of rhEPO by used method as per IP 2018 at NIB is well standardized and validated method. Therefore, it is essential that a robust, well-characterized methodology be applied to ensure batch-to-batch consistency in biopotency among the different manufacturers in order to guarantee high quality and therapeutic efficacious Erythropoietin in Indian market....
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