Memo to the FDA and ICH: appeal for in vivo drug target identification and target pharmacokinetics. Recommendations for improved procedures and requirements

Drug Discovery Today

Volumn 12, Issue 15-16, 2007, Pages 594-598

  Stumpf, Walter E ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBON 14; VITAMIN D; VITAMIN D DERIVATIVE;

AUTORADIOGRAPHY; BIOAVAILABILITY; DRUG DISTRIBUTION; DRUG INDUSTRY; DRUG TARGETING; FOOD AND DRUG ADMINISTRATION; HORMESIS; IN VITRO STUDY; IN VIVO STUDY; MEDICAL LITERATURE; MEDICAL SOCIETY; METHODOLOGY; RADIOASSAY; SHORT SURVEY;

ANIMALS; DRUG DELIVERY SYSTEMS; GUIDELINES; HUMANS; INTERNATIONAL COOPERATION; MANDATORY REPORTING; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34547804256     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2007.06.006     Document Type: Short Survey

References (23)

1. Koelle G.B. Concluding remarks. In: Roth L.J., and Stumpf W.E. (Eds). Autoradiography of Diffusible Substances (1969), Academic Press 363
2. Doull J. Toxicology comes of age. Annu. Rev. Pharmacol. 41 (2001) 1-21
3. Strulovici B. The assay development challenge. Drug Discov. Dev. 9 (2006) 30-36 (Cit. in McGee, P.)
4. Langer O., and Mueller M. Methods to assess tissue-specific distribution and metabolism of drugs. Curr. Drug Metab. 5 (2004) 463-481
5. Lin J.H. Tissue distribution and pharmacodynamics: a complicated relationship. Curr. Drug Metab. 7 (2006) 39-65
6. Eichler H.-G., and Mueller M. Drug distribution the forgotten relative in clinical pharmacokinetics. Clin. Pharmacokinet. 34 (1998) 95-99
7. In: Roth L.J., and Stumpf W.E. (Eds). Autoradiography of Diffusible Substances (1969), Academic Press
8. Monro A.M. Are routine tissue distribution studies justifiable for approval of human drugs?. Drug Metab. Dispos. 22 (1994) 341-342
9. 3 (OCT) in rat parathyroid, kidney distal and proximal tubules, duodenum, and skin, studied by quantitative receptor autoradiography. J. Histochem. Cytochem. 46 (1998) 1351-1358
10. Veldstra H. Synergism and potentiation with special reference to the combination of structural analogues. Pharmacol. Rev. 8 (1956) 339-387
11. Stumpf W.E. Drug localization in tissues and cells (2003), IDDC-Press, University of North Carolina at Chapel Hill Bookstore
12. Stumpf W.E. Drug localization and targeting with receptor microscopic autoradiography. J. Pharmacol. Toxicol. Methods 51 (2005) 25-40
13. Stumpf W.E. Limitations of whole body autoradiography without receptor microautoradiography. J. Pharmacol. Toxicol. Methods 48 (2002) 127-128
14. Narbaitz R., et al. The role of autoradiographic and immunocytochemical techniques in the clarification of sites of metabolism and action of vitamin D. J. Histochem. Cytochem. 29 (1981) 91-100
15. In: Stumpf W.E., and Solomon H. (Eds). Autoradiography and Correlative Imaging (1995), Academic Press
16. Stumpf W.E. Vitamin D sites and mechanisms of action: a histochemical perspective. Reflections on the utility of autoradiography and cytopharmacology for drug targeting. Histochem. Cell Biol. 104 (1995) 417-427
17. In: Stumpf W.E., and Grant L.D. (Eds). Anatomical Neuroendocrinology (1975), S. Karger
18. Sandgren M.G., et al. Tissue distribution of the 1,25-dihydroxyvitamin D3 receptor in the male rat. Biochem. Biophys. Res. Commun. 181 (1991) 611-616
19. Colston K., et al. Organ distribution of the cytoplasmic 1,25-dihydroxycholecalciferol receptor in various mouse tissues. Endocrinology 107 (1980) 1916-1922
20. Waddell W.J. Localization and metabolism of drugs in the fetus. Fed. Proc. 31 (1972) 52-61
21. Calabrese E.J., and Baldwin L.A. Hormesis: a generalizable and unifying hypothesis. Crit. Rev. Toxicol. 31 (2001) 353-424
22. Stumpf W.E. The dose makes the medicine. Drug Discovery Today 11 (2006) 550-555
23. Stumpf W.E. Editorial. The main role of vitamin D: seasonal regulation of vital functions. High-resolution target recognition leads to a new paradigm and advanced drug development. Eur. J. Drug Metab. Pharmacokinet. 32 (2007) 1-6