Microdosing in Phase O: A Q&A with J. Scott Tarrant, Xceleron - Pharmaceutical Technology

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Microdosing in Phase O: A Q&A with J. Scott Tarrant, Xceleron
J. Scott Tarrant, executive vice-president of Xceleron, explains the role of microdosing in drug development. He describes how microdose data can be used to predict pharmacological dose absorption, distribution, metabolism, and excretion/pharmacokinetic outcomes using accelerator mass spectrometry.


Pharmaceutical Technology


References

1. FDA, Guidance for Industry, Investigators and Reviewers. Exploratory IND Studies including Human Microdose Studies (Rockville, MD, Jan. 2006).

2. European Medicines Agency, "Position Paper on Nonclinical Safety Studies to Support Clinical Trials with a Single Microdose" (London, June 23, 2004).

3. EUMAPP, "European Union Microdose AMS Partnership Program (EUMAPP) Background Paper" (York, UK, Jan. 2006).

4. G. Lappin et al., "Use of Microdosing to Predict Pharmacokinetics at the Therapeutic Dose: Experience with Five Drugs," Clin. Pharmacol. Ther. 80 (3), 203–215 (2006).

5. G. Lappin and R.C. Garner, "Big Physics, Small Doses: The Use of AMS and PET in Human Microdosing of Development Drugs," Nat. Rev. Drug Dis. 2 (3), 233–240 (2003).

6. P. Sandhu et al., "Evaluating of Microdosing Strategies for Studies in Preclinical Drug Development: Demonstration of Linear Pharmacokinetics in Drugs of a Nucleoside Over a 50-Fold Dose Range," Drug Metab. Dispos. 32 (11), 1254–1259 (2004).

7. S.K. Balani et al, "Evaluation of Microdosing to Assess Pharmacokinetic Linearity in Rats Using Liquid Chromatography–Tandem Mass Spectrometry," Drug Metab. Dispos. 34 (3), 384–388 (2006).

8. N. Yamane et al, "Microdose Clinical Trial: Quantitative Determination of Fexofenadine in Human Plasma Using Liquid Chromatography/Electrospray Ionization Tandem Mass Spectrometry," J. Chromatogr., B. Analyt. Technol. Biomed Life Sci. 858 (1–2), 118–128 (2007).

9. Le.T. Vuong et al., "Use of Accelerator Mass Spectrometry to Measure the Pharmacokinetics and Peripheral Blood Mononuclear Cell Concentrations of Zidovudine," J. Pharm. Sci. 97 (7), 2833–2843 (2007).

10. Z. O'Brien, "Using Microdosing and AMS Analysis to Compare Clinical Pharmacokinetics of Four Development Drugs with Diphenhydramine," presented at AAPS Annual Meeting, San Diego, CA, Nov., 2007.

11. Speedel, "SPP635," (Basel, Switzerland), http:// http://www.speedel.com/section/4/subsections/5/, accessed July 14, 2008.

12. J. Ni et al., "Microdosing Assessment to Evaluate Pharmacokinetics and Drug Metabolism in Rats using Liquid Chromatography-Tandem Mass Spectrometry," Pharm. Res. 25 (7), 1572–1582 (2008).


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