Examples of in vitro-in vivo relationships with a diverse range of quality

Advances in Experimental Medicine and Biology

Volumn 423, Issue , 1997, Pages 1-15

  Rackley, Russell J ^a  

^a Biopharmaceutics Purepac Pharmaceutical Co   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOEQUIVALENCE; CORRELATION FUNCTION; DRUG ABSORPTION; DRUG DOSAGE FORM; DRUG SOLUBILITY; FOOD DRUG INTERACTION; IN VITRO STUDY; IN VIVO STUDY; LINEAR SYSTEM; PHARMACEUTICS; PRIORITY JOURNAL; STATISTICAL ANALYSIS; SUSTAINED RELEASE PREPARATION;

EID: 0030739197     PISSN: 00652598     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-4684-6036-0_1     Document Type: Article

References (31)

1. AAPS/USP/FDA Workshop on Scale-Up of Extended-Release Dosage Forms; Crystal Gateway Mariott Hotel, Arlington, VA; Sept. 8-10, 1992;
2. and Skelly JP, Van Buskirk GA, Arbit HM, et al.; Pharm Res 10(12):1800-1805, 1993.
3. Pharmacopeial Forum; July-August, 1988; pg. 4160.
4. Cardot JM and Beyssac E, Eur J Drug Metab Pharmacokin, 18(1): 113-120, 1993.
5. Skelly JP and Shiu GF; Eur J Drug Metab Pharmacokin, 18(1):121-129, 1993.
6. Cohen JL, Hubert BB, Leeson LJ, et al.; Pharm Res, 7:983-987, 1990.
7. Lindenbaum J, Butler VP, Murphy JE et al.; Lancet, June 2(1):1215-1217, 1973.
8. Johnson BF, McCrerie J, Greer H, et al.; Lancet, June 30(1):1473-1475, 1973.
9. Shaw TRD, Raymond K, Howard MR, et al.; Br Med J, 4:763-766, 1973.
10. Leeson LJ; LJL Associates, Inc., personal communication.
11. Siewert M; Eur J Drug Metab Pharmacokin, 18(1):7-18, 1993.
12. Oosterhuis B and Jonkman JHG; Eur J Drug Metab Pharmacokin, 18(1):19-30, 1993.
13. Pharmacopeial Forum, 19(3):5366-5379; May-June, 1993.
14. Generic Drugs Advisory Committee, Open Session; Rockville, MD; Jan. 11-12, 1994.
15. Wagner JG and Nelson E; J Pharm Sci, 52(6):610-611, 1963.
16. Loo JCK and Riegelman S; J Pharm Sci, 57:918-928, 1968.
17. Gillespie WR; PCDCON: Deconvolution for Pharmacokinetic Applications; The University of Texas at Austin, Austin, TX.
18. Chan K, Langenbucher F, and Gibaldi M; J Pharm Sci, 76(6):446-450, 1987.
19. PCNONLIN; Statistical Consultants, Inc.; Lexington, KY.
20. SAS; SAS Institute, Inc.; Cary, NC.
21. NONMEM; NONMEM Project Group, University of California; San Francisco, CA.
22. Leeson LJ, Adair D, Clevenger J, et al.; J Pharmacokin Biopharm, 13(5):493-514, 1985.
23. STELLA II; High Performance Systems, Inc.; Hanover, NH.
24. Hwang SS, Bayne W, Theeuwes F; J Pharm Sci, 82(11): 1145-1150, 1993.
25. Holford NHG and Sheiner LB; Clin Pharmacokin, 6:429-453, 1981.
26. Langenbucher F; Pharm Ind, 38(5):472-477, 1976.
27. Rescigno A; Pharm Res, 9(7):925-928, 1992.
28. Moore JW and Flanner HH, Pham Tech, June 1996, pg 64-74.
29. McCall TW. Diehl D, Baumgarner C, et al.; 11th Annual AAPS Meeting, October, 1996, Poster PDD 7279 [TIMERx is a trademark of TIMERx Technologies].
30. USP XXII; Chapter 〈711〉, pg 1578-1579; and Chapter 〈724〉, pg 1580-1581.
31. Malinowski H, Marroum P, Uppoor VR, et al.; Guidance for Industry; Extended Release Solid Oral Dosage Forms; Development, Evaluation, and Application of in vitro - in vivo Correlations; Center for Drug Evaluation and Research (CDER), July 1, 1996.