(已有国家标准化学药品研究技术指导原则.docVIP

已有国家标准化学药品研究 技术指导原则 目 录如果标准中未规定杂质限度，产品的杂质含量明显高于已上市的同品种的杂质实测值1. FDA Guidance for industry ANDAs: impurities in drug substances, Nov. 1999 2. FDA Guidance for industry Court decisions, ANDAs approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the federal food, drug, and cosmetic act. Mar. 2000 3. FDA Guidance for industry 180-day exclusivity when multiple ANDAs are submitted on the same day. July 2003 4. FDA Guidance for industry Listed drugs, 30-month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare prescription drug, improvement, and modernization act of 2003, Questions and answers Oct. 2004 (Draft guidance) 5. FDA Guidance for industry bioavailability and bioequivalence studies for orally administered drug products-general considerations, March 2003. 6. FDA Guidance for industry extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlation, Sep 1997. 7. FDA Guidance for industry Topical dermatological drug product NDAs and ANDAs -in vivo bioavailability and bioequivalence, in vitro release, and associated studies, June 1998. (Draft guidance) 8. EMEA Notes for guidance on the investigation of bioavailability and bioequivalence. July 2001. 9. MALAYSIA The conduct of bioavailability and bioequivalence studies. Sep 2000. 10. MHW Guideline for bioequivalence studies of generics products, Dec 1997. 11. Roger L. Williams, Md et al, Equivalence approaches, Clin Pharmacol Ther 2002; 72:229-37 六、著者 已有国家标准化学药品技术指导原则课题研究组 28