Investigation of FDA Issued List and Guidance for Bioequivalence Recommendations for Specific Products Related with Narrow Therapeutic Index Drugs / 中国药学杂志

OBJECTIVE: To investigate FDA issued lists and guidance on Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs.METHODS: FDA issued lists and Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs was investigated in multiple aspects, including detailed drugs lists, bioequivalence study designs, selection of bioequivalence subjects,analytes to measure,bioequivalence waiver, selection of reference products.RESULTS: Keeping updated lists and Bioequivalence Recommendations for Specific Products relative with Narrow Therapeutic Index Issued by FDA are to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment.CONCLUSION: Narrow therapeutic index list and Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA have not released similar list and guidance on specific narrow therapeutic index.

Introduction and analysis of guidance for industry bioequivalence recommendations for specific products issued by FDA / 中国药学杂志

OBJECTIVE: To investigate Guidance for Industry Bioequivalence Recommendations for specific products issued by FDA. METHOD: Combination with FDA and CFDA issued guidance related to Bioequivalence (up to May 20th, 2016), 185 FDA issued Guidance for Bioequivalence Recommendations for Specific Products were discussed, which are involved in the CFDA announced initial list of the equivalence assessment of quality and curative effect for generic products. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLUSION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA haven't released similar guidance on specific products yet.

A survey of international guidelines for bioequivalence of systemically available orally administered generic drug products / 中国药学杂志

OBJECTIVE: To investigate similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. METHODS: The comparisons of these bioequivalence recommendations were performed and based on bioequivalence study designs, selection of bioequivalence subjects,dosage, selection of reference products, method of pharmacokinetic calculations and bioequivalence acceptance limits, bioequivalence waiver on multiple-strength products and and implementation of the Biopharmaceutics Classification System, which are issued by Australia, the European Medicines Association, Japan,the USA, and the World Health Organization. RESULTS: There were lots of differences were found in bioequivalence approaches among the regulatory authorities surveyed, although there are more similarities. CONCLUSION: Discussion of the similarities and differences among bioequivalence approaches used by international regulatory authorities would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China.

Study of a novel compound 2460A with activities produced by fungus / 药学学报

With IL-6R as target, a new compound 2460A was identified from fungus using HTS screening model. The taxonomics of the produced strain was confirmed to be Trichoderma hazianum rifai after sequencing analysis of rDNA-ITS (internal transcribed spacer). Results showed that this compound has a binding activity on IL-6R competed with IL-6, thus it is a new ligand of IL-6R originating from microbe. With MTT assay, the anti-tumor activities of 2460A were demonstrated on CM126 and HT-29 cell lines separately, the IC50 are 2.17 x 10(-5) mol x L(-1) and 1.8 x 10(-5) mol x L(-1) respectively. The compound affected lightly the HT-29 cell cycle at S phase. Studies for the anti-tumor activity of 2460A in vivo are in progress in our lab.

A IL-6R antagonist 2520A produced by a fungal species / 药学学报

<p><b>AIM</b>To isolate IL-6R antagonists from the cultured broth of the strain Torulomyces ovatus.</p><p><b>METHODS</b>Various column chromatographyes were used to separate and purify the compounds with IL-6R antagonist activity. The spectral data and physic-chemical properties were measured for structure identification.</p><p><b>RESULTS</b>One compound namely 2520 was isolated from the cultured broth of Torulomyces ovatus.</p><p><b>CONCLUSION</b>2520A is a known compound (ferrichrome). It is first reported about its antagonistic activity of IL-6R and identification of iron atom in its structure.</p>