上海cmc培训生物利用度和生物等效性在仿制药和刘新药申请中的法规要求.ppt

Types of 505(b)(2) NDAs505(b)(2) 新药类型 New Chemical Entity (rarely) Changes to a previously approved drug New dosage form, dosing regimen, strength, or route of administration New indication New active ingredient New inactive ingredient that requires studies beyond limited confirmatory studies Rx ? OTC switch (Claritin) Duplicates of approved drugs that cannot be approved under an ANDA Features of 505(b)(2) Product?505(b)(2) 新药特点 Not a completely new product, Not a generic, A product with some differences from a previously approved product. Approval requires clinical data, but the studies may have been conducted by others. The applicant and FDA may rely on prior FDA safety and efficacy determinations, based on studies conducted by someone else even though the applicant does not have a right of reference to the data. 21 U.S.C. § 355(b)(2) Safety and efficacy can also be supported by published reports Patent and Exclusivity Issues 505(b)(2) 新药专利 A 505(b)(2) product may itself qualify for 3 or 5 years of new drug exclusivity 3-year exclusivity requires: New clinical studies (other than BE studies) Conducted by the applicant Essential to the approval of the application 5-year exclusivity for New Chemical Entities NCEs can be old drugs (i.e., ingredient never approved under an NDA) CONTACT INFORMATIONJIM WEI513-763-9770E-MAIL:? weijim@ Thank you! 谢谢 * * This plot is the actual data from the study High lighted are some subjects with the greatest variability between doses. The same subjects contribute to the high WSV of Cmax and AUC The next slide shows these 6 subjects only * * * Bioavailability and Bioequivalence Study in Generic and new Drug Applications生物利用度和生物等效性在仿制药和新药申请中的法规要求 魏晓雄 Jim Wei, MD, PhD x.wei@ AAPS/CPA Workshop Shanghai, June 28-29, 2010 Agenda议程 General BA/BE生物利用度和生物等效性内容概述 Biowaiver 生物等效性试验豁免 Regulatory requirements for BE supplies, sample storage and data analysis 生物等效性试验的法规要求 BE and 505(b)(2) NDA 生物等效性和505(b)(2) 类新药上市申报申请