Regulation of pharmaceutical excipients

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Volumn , Issue , 2006, Pages 37-50

  Pinco, Robert G ^a   Sullivan, Theodore M ^a  

^a Buchanan Ingersoll PC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84971261096     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (15)

1. Webster’s II New College Dictionary. Boston, Massachusetts: Houghton Mifflin Company, 1995: 391.
2. U.S. Department of Health and Human Services. Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. Food and Drug Administration, May 2005.
3. 21 C.F.R. x 330.1(e).
4. 42 Fed. Reg. 19156 (April 12, 1977).
5. Carol Ballentine. Taste of Raspberries, Taste of Death: the 1937 Elixir Sulfanilamide Incident. FDA Consumer magazine, June 1981.
6. 21 C.F.R. x 314.50(d) (1) (ii).
7. ICH Guideline S7A: Safety Pharmacology Studies for Human Pharmaceuticals. Add citation for ICH S7 guidance.
8. Guidance for Industry: Nonclinical Studies for Development of Pharmaceutical Excipients. Food and Drug Administration 2005.
9. U.S. Department of Health and Human Services. Inactive Ingredient Guide. Food and Drug Administration.
10. http://www.fda.gov/cder/drug/iig/.
11. 21 C.F.R.x 171.
12. 21 C.F.R. x 170.30.
13. 21 C.F.R. x 170.30(d).
14. 21 C.F.R. x 170.35.
15. PhEur. Vol. 14. No 2, April 2002.