Microdosing: The new pharmacokinetic paradigm?

Consultant Pharmacist

Volumn 21, Issue 10, 2006, Pages 756-776

  Zanni, Guido R ^a   Wick, Jeannette Y ^b  

^a National Institutes of Health ^*

^b NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Bioavailability; Clinica trials; CREAM trial; Investigational new drugs; Microdosing; Pharmacokinetics; Phase 0 cinical trials

Indexed keywords

DIAZEPAM; DRUG; ERYTHROMYCIN; MIDAZOLAM; MONOCLONAL ANTIBODY; TGN 1412; UNCLASSIFIED DRUG; WARFARIN; ZK 253;

CLINICAL TRIAL; CYTOKINE RELEASE SYNDROME; DISTRIBUTION VOLUME; DOSE RESPONSE; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG HALF LIFE; DRUG MARKETING; DRUG METABOLISM; FEVER; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPOTENSION; IMMUNOPATHOLOGY; MASS SPECTROMETRY; NONHUMAN; POSITRON EMISSION TOMOGRAPHY; REVIEW; RIGOR;

EID: 33750336352     PISSN: 08885109     EISSN: None     Source Type: Journal    
DOI: 10.4140/tcp.n.2006.757     Document Type: Review

References (20)

1. Food and Drug Administration. Guidance for Industry, investigators, and reviewers - exploratory IND studies. January 2006. Available at http://www.fda.gov/cder/guidance/7086fnl.htm. Accessed July 6, 2006.
2. Garner RC, Lappin G. The phase 0 microdosing concept. Br J Clin Pharmacol 2006;61:367-70.
3. Wilding IR, Bell JA. Improved early clinical development through human microdosing studies. Drug Discov Today 2005;10:890-4.
4. Wilding IR. Use of human microdosing studies to improve the pharmacokinetic/bioavailability (PK/BA) quality of new drug candidates: a practical guide. In: Clinical research manual. Luscombe D, Stonier P. (eds). 2005 Euromed Communications; 2005; Haslemere, England UK. Available at http://www.microdosing.co. uk/pdf/Practical_guide_to_microdos.pdf. Accessed July 3, 2006.
5. Lappin G, Garner RC. Big physics, small doses: the use of AMS and PET in human microdosing of development drugs. Nat Rev Drug Discov 2003;2:233-40.
6. Food and Drug Administration. Why does FDA think the critical path infrastructure needs to be modernized? Available at http://www. fda.gov/oc/initiatives/criticalpath/faq.html. Accessed July 5, 2006.
7. Koreith K. Zeroing in on microdosing. The CenterWatch Monthly 2005;12:1, 11-7. Available at http://www.acciumbio.com/CenterWatch%20(Microdosing)%20- %20Feb%2005.pdf. Accessed July 8, 2006.
8. Food and Drug Administration. The critical path to new medical products. Available at http://www.fda.gov/oc/initiatives/critical-path/initiative.html. Accessed July 5, 2006.
9. Garner RC. Less is more: the human microdosing concept. Drug DiscovToday 2005:10;449-51.
10. Lappin G, Garner RC. Current perspectives of 14C-isotope measurement in biomedical accelerator mass spectrometry. Anal Bioanal Chem 2004;378:356-64.
11. Medical News Today. Pharmaceutical profiles completes human microdosing study. July 24, 2004. Available at http://www.medical-newstoday.com/medicalnews. php?newsid-113 94. Accessed July 7, 2006.
12. EMEA Position paper on the nonclinical safety studied to support clinical trials with a single microdose. June 2004. Available at http://www.emea.eu.int/ pdfs/human/swp/25 9902en.pdf. Accessed July 7, 2007.
13. Manitpisitkul P, White RE. Whatever happened to cassette-dosing pharmacokinetics? Drug Discov Today 2004;9:652-8.
14. Microdosing trial produces good result. Pharma Marketletter Feb 21, 2005:1.
15. Tripep. The negative results from the alfaHGA study in Thailand makes Tripep refocus on ChronVac-C®. Press release April 4, 2006. Available at http://www.tripepeng.webbinfo. nu/. Accessed July 14, 2006.
16. Microdosing boosts progress of Speedel's renin inhibitor trial, (pharmaceutical industry) Pharma Marketletter Feb 21, 2005:1.
17. Tales of the unexpected; medicine (problems with a drug trial). The Economist 2006;378:78.
18. Corbishley A. Accidental underdose. New Scientist 2006;190:20.
19. Urgent changes needed for authorisation of phase I trials. Lancet 2006;367:1214.
20. Rosental E. British rethinking test rules after drug nearly kills 6. New York Times April 8, 2006:A1(L).