A selection of publications by CDDS faculty and fellows

Tannenbaum S, Holford NHG, Lee H, Peck C, Mould DR. Simulation of Correlated Continuous and Categorical Variables using a Single Multivariate Distribution. Journal of Pharmacokinetics and Pharmacodynamics, 2006 Dec;33(6):773-94

Lee H, Yim D-S, Zhou H, Peck CC. Evidence of Effectiveness: How Much Can We Extrapolate From Existing Studies? AAPS Journal. 2005; 07(02): Article 47

Lack NA, Green B, Dale DC, Calandra GB, Lee H, MacFarland RT, Badel K, Liles WC, Bridger G, A Pharmacokinetic/Pharmacodynamic Model for the Mobilization of CD34+ Hematopoietic Progenitor Cells by AMD3100, Clin Pharmacol Ther 2005;77(5): 427-36

Yim, D-S, Zhou, H, Buckwalter, M, Nesterov, I, Peck, CC. Lee, H. Population Pharmacokinetic Analysis and Simulation of the Time Concentration Profile of Etanercept in Pediatric Patients with Juvenile Rheumatoid Arthritis, J Clin Pharmacol 2005;45:246-256.

Peck, CC, Rubin, DB, Sheiner, LB. Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin Pharm Ther 2003, 73:481-490.

Lee, H, Kimko, HC, Rogge, M, Wang, D, Nestorov, I, Peck, CC. Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis. Clin Pharmacol Ther 2003;73:348-65.

Kraiczi, H, Jang, T, Ludden, T, Peck, CC. Randomized concentration-controlled trials: motivations, use and limitations. Clin Pharm Ther 2003; 74/3 pp. 203-214

Cross, J, Lee, H, Westelinck, A, Nelson, J, Grudzinskas, C, Peck, C. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Pharmacoepidemiology Drug Safety 2002, 11 (6): 439-446.

Holford NHG, DR Mould and C Peck. "Disease Progression Models" in Principles of Clinical Pharmacology, Editor: A. Atkinson Academic Press New York NY, 2001.

Staschen C-M, RR Bies, NHG Holford, CC Peck and M Eldon. "Regression analysis of a physiologically based pharmacokinetic model (PBPK) for a1-Protease-Inhibitor (API) after IV-infusion." Clin Pharm Ther 69 (2): 87, 2001.

Biomarkers Definitions Working Group. "Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework." Clin Pharm Ther 69 (3): 89-95, 2001.

Galluppi GR, MC Rogge, LK Roskos, LJ Lesko, MD Green, DW Feigal, and CC Peck. "Integration of pharmacokinetics and pharmacodynamics studies in the discovery, development and review of protein therapeutic agents: a conference report." Clin Pharm Ther, 2001.

Kimko HC, SSB Reele, NHG Holford, and CC Peck. "Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumerate; Seroquel) by simulation employing a population pharmacokinetic model." Clin Pharm Ther 68 (5): 568-577, 2000.

Mould DR. "Defining Covariate Distribution Models for Clinical Trial Simulation" in Simulation for Defining Clinical Trials, Editors: H. Kimko and S Duffell Marcel Dekker, New York, NY, 2001.

Holford NHG, Monteleone JPR, Kimko HC, Peck CC: ÒSimulation of Clinical TrialsÓ. In Annual Rev Pharmacol Toxicol. Vol. 40, 209-234, 2000.

Kimko HC, J Cross, and D Abernethy. "Pharmacokinetics and pharmacodynamics of methylphenidate." Clin Pharmacokinet 37 (6):457-470, 1999

Krall RL, KH Engleman, HC Ko, and CC Peck. "Clinical Trial Modeling and Simulation — Warner KE, Peck CC, Work in Progress." Drug Info J, 32: 971-976, 1998.

Peck CC. "Drug development: Improving the process." Food and Drug Law J. 52 (2):163-167, 1997.

Reigner BG, PEO Williams, IH Patel, J-L Steimer, CC Peck, and P van Brummelen. "An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development." Clin Pharmacokinet, 33(2): 142-52, 1997.

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