|
|
 |
|
|
|
|
2. Department of the Treasury: Report on Medical Equipment and Pharmaceuticals Market-Oriented, Sector-Selective (MOSS) Discussions, January 1986. |
|
|
|
|
|
|
|
|
3. W. J. C. Currie and R. W. J. Currie. Registration of Drugs, Encyclopedia of Pharmaceutical Technology. Marcel Dekker, Inc., in press. |
|
|
|
|
|
|
|
|
4. P. F. D'Arcy and D. W. G. Haron, Eds. Proceedings of the First International Conference on Harmonization. A Queen's University of Belfast Publication, 1992. |
|
|
|
|
|
|
|
|
5. P. F. D'Arcy and D. W. G. Haron, Eds. Proceedings of the Second International Conference on Harmonization. A Queen's University of Belfast Publication, 1994. |
|
|
|
|
|
|
|
|
6. Plenary Session: Background to the Conference. Second International Conference on Harmonization, 1993, p. 4. |
|
|
|
|
|
|
|
|
7. Drug Registration in Japan, 5th ed. Yakuji Nippo LTD, Tokyo, Japan, 1993. |
|
|
|
|
|
|
|
|
8. PAB Notification, No. 698. May 1980. |
|
|
|
|
|
|
|
|
9. PMA Survey of NDA Processing in Japan, 1993. Pharmaceutical Research and Manufacturers of America, Internal Report. |
|
|
|
|
|
|
|
|
10. PAB Notification, No. 698. May 1980. |
|
|
|
|
|
|
|
|
11. PAB Notification, No. 970. October 1976. |
|
|
|
|
|
|
|
|
12. PAB Notification, No. 774. October 1983. |
|
|
|
|
|
|
|
|
13. PCD Notification, No. 43. February 1991. |
|
|
|
|
|
|
|
|
14. PCD Notification, No. 30. April 1994. |
|
|
|
|
|
|
|
|
15. G. Melien. Stability studies in the E.C., the U.S. and Japan. Reg. Affairs J. 2: 878883, 1991. |
|
|
|
|
|
|
|
|
16. PCD Notification, No. 43. February 1991. |
|
|
|
|
|
|
|
|
17. Guidelines for Toxicity Study of Drugs Manual. Yakuji Nippo LTD, Tokyo, Japan, 1994. |
|
|
|
|
|
|
|
|
18. NDD Notification, No. 4. January 1991. |
|
|
|
|
|
|
|
|
19. PAB Notification, No. 6. January 1991. |
|
|
|
|
|
|
|
|
20. C. E. Lumley et al. An international appraisal of the minimum duration of chronic animal toxicity studies. Hum. Exp. Toxicol. 11: 155162, 1992. |
|
|
|
|
|
|
|
|
21. R. Bass et al. Draft guidelines on detection of toxicity to reproduction for medicinal products. Adverse Drug React. Toxicol. Rev. 3: 127141, 1991. |
|
|
|
|
|
|
|
|
22. C. E. Lumley. Proposal for international guidelines for reproductive and developmental toxicity testing for pharmaceuticals. Adverse Drug React. Toxicol. Rev. 2: 143153, 1991. |
|
|
|
|
|
|
|
|
23. Report of working group on relevance of animal toxicology for predicting human adverse events, 1992. Pharmaceutical Manufacturers Association of Japan, Internal Report. |
|
|
|
|
|
|
|
|
24. PAB Notification, No. 970. October 1976. |
|
|
|
|
|
|
|
|
25. PAB Notification, No. 315. March 1982. |
|
|
|
|
|
|
|
|
26. PAB Notification, No. 313. March 1982. |
|
|
|
|
|
|
|
|
27. NDD Notification, No. 43. June 1992. |
|
|
|
|
|
|
|
|
28. NDD Notification, No. 20. March 1992. |
|
|
|
|
|
|
|
|
29. PAB Notification, No. 660. June 1985. |
|
|
|
|
|
|
|
|
30. NDD Notification, No. 104. December 1993. |
|
|
|
|
|
|
|
|
31. R. Temple. Food and Drug Administration's Guidelines for Clinical Testing of Drugs in the Elderly. Drug Information Journal 19: 483486, 1985. |
|
|
|
|
|