Carl Peck, MD
Professor
Bioengineering
School of Pharmacy

Publications (71)

Top publication keywords:
Clinical Trials as TopicDrugs, GenericBayes TheoremProduct Surveillance, PostmarketingDrug and Narcotic ControlPharmaceutical PreparationsPharmacokineticsTherapeutic EquivalencyUnited States Food and Drug AdministrationPharmacology, ClinicalDecision Making, OrganizationalPharmaceutical ResearchDrug ApprovalDrug EvaluationPharmacology

• The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.
  The AAPS journal 2024 Fang L, Gong Y, Hooker AC, Lukacova V, Rostami-Hodjegan A, Sale M, Grosser S, Jereb R, Savic R, Peck C, Zhao L
• Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies.
  The AAPS journal 2022 Peck C, Campbell G, Yoo I, Feng K, Hu M, Zhao L
• Probability of Success: A Crucial Concept to Inform Decision Making in Pharmaceutical Research and Development.
  Clinical pharmacology and therapeutics 2021 Lalonde RL, Peck CC
• Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929-2020).
  Clinical pharmacology and therapeutics 2020 Temple RJ, O'Neill RT, Peck CC
• Scientific considerations for global drug development.
  Science translational medicine 2020 Wilson JL, Cheung KWK, Lin L, Green EAE, Porrás AI, Zou L, Mukanga D, Akpa PA, Darko DM, Yuan R, Ding S, Johnson WCN, Lee HA, Cooke E, Peck CC, Kern SE, Hartman D, Hayashi Y, Marks PW, Altman RB, …

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• Sir Alasdair Breckenridge 1937-2019. A Celebratory Tribute.
  Clinical pharmacology and therapeutics 2020 Peck CC, Breckenridge RA
• Report on the current status of the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulation.
  British journal of clinical pharmacology 2019 Breckenridge AM, Breckenridge RA, Peck CC
• Bayesian Approach to Establish Bioequivalence: Why and How?
  Clinical pharmacology and therapeutics 2019 Peck CC, Campbell G
• Individualized treatment strategies for hyperuricemia informed by a semi-mechanistic exposure-response model of uric acid dynamics.
  Physiological reports 2018 Aksenov S, Peck CC, Eriksson UG, Stanski DR
• Farewell to Our Good Friend, Outstanding Mentor, and Colleague Darrell R. Abernethy (1949-2017).
  Clinical pharmacology and therapeutics 2018 Schwartz JB, Woosley RL, Peck CC
• Poor medication adherence in clinical trials: consequences and solutions.
  Nature reviews. Drug discovery 2017 Breckenridge A, Aronson JK, Blaschke TF, Hartman D, Peck CC, Vrijens B
• Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013.
  Drug design, development and therapy 2016 Suh HY, Peck CC, Yu KS, Lee H
• Farewell to our Good Friend and Outstanding Colleague David Flockhart (1952-2015).
  Clinical pharmacology and therapeutics 2016 Peck CC, Woosley RL
• Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years.
  Journal of pharmaceutical sciences 2012 Rowland M, Noe CR, Smith DA, Tucker GT, Crommelin DJ, Peck CC, Rocci ML, Besançon L, Shah VP
• Physiologically-based pharmacokinetics in drug development and regulatory science.
  Annual review of pharmacology and toxicology 2011 Rowland M, Peck C, Tucker G
• Quantitative clinical pharmacology is transforming drug regulation.
  Journal of pharmacokinetics and pharmacodynamics 2010 Peck CC
• A roadmap for biomarker qualification.
  Nature biotechnology 2010 Warnock DG, Peck CC
• Recommended changes to oncology clinical trial design: revolution or evolution?
  European journal of cancer (Oxford, England : 1990) 2007 Ratain MJ, Humphrey RW, Gordon GB, Fyfe G, Adamson PC, Fleming TR, Stadler WM, Berry DA, Peck CC
• "Getting the dose right": facts, a blueprint, and encouragements.
  Clinical pharmacology and therapeutics 2007 Peck CC, Cross JT
• Preventing postmarketing changes in recommended doses and marketing withdrawals.
  Ernst Schering Research Foundation workshop 2007 Peck C
• Current issues relating to drug safety especially with regard to the use of biomarkers: a meeting report and progress update.
  European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences 2006 Rolan P, Danhof M, Stanski D, Peck C
• Simulation of correlated continuous and categorical variables using a single multivariate distribution.
  Journal of pharmacokinetics and pharmacodynamics 2006 Tannenbaum SJ, Holford NH, Lee H, Peck CC, Mould DR
• Evidence of effectiveness: how much can we extrapolate from existing studies?
  The AAPS journal 2005 Lee H, Yim DS, Zhou H, Peck CC
• Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis.
  Journal of clinical pharmacology 2005 Yim DS, Zhou H, Buckwalter M, Nestorov I, Peck CC, Lee H
• Physiologically based pharmacokinetics in drug development and regulatory science: a workshop report (Georgetown University, Washington, DC, May 29-30, 2002).
  AAPS pharmSci 2004 Rowland M, Balant L, Peck C
• Randomized concentration-controlled trials: motivations, use, and limitations.
  Clinical pharmacology and therapeutics 2003 Kraiczi H, Jang T, Ludden T, Peck CC
• Postmarketing drug dosage changes.
  Pharmacoepidemiology and drug safety 2003 Peck CC
• Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval.
  Clinical pharmacology and therapeutics 2003 Peck CC, Rubin DB, Sheiner LB
• Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis.
  Clinical pharmacology and therapeutics 2003 Lee H, Kimko HC, Rogge M, Wang D, Nestorov I, Peck CC
• Biological sex analysis in clinical research.
  Journal of women's health & gender-based medicine 2000 Woosley RL, Anthony M, Peck CC
• Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model.
  Clinical pharmacology and therapeutics 2000 Kimko HC, Reele SS, Holford NH, Peck CC
• A pharmacodynamic Markov mixed-effects model for the effect of temazepam on sleep.
  Clinical pharmacology and therapeutics 2000 Karlsson MO, Schoemaker RC, Kemp B, Cohen AF, van Gerven JM, Tuk B, Peck CC, Danhof M
• Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
  Journal of clinical pharmacology 2000 Lesko LJ, Rowland M, Peck CC, Blaschke TF
• Assessment and reporting of clinical pharmacology information in drug labeling.
  Clinical pharmacology and therapeutics 2000 Spyker DA, Harvey ED, Harvey BE, Harvey AM, Rumack BH, Peck CC, Atkinson AJ, Woosley RL, Abernethy DR, Cantilena LR
• Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
  European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences 2000 Lesko LJ, Rowland M, Peck CC, Blaschke TF, Breimer D, de Jong HJ, Grahnen A, Kuhlmann JJ, Stewart B
• Simulation of clinical trials.
  Annual review of pharmacology and toxicology 2000 Holford NH, Kimko HC, Monteleone JP, Peck CC
• Dr Marcus M. Reidenberg, recipient of the 1999 Harry Gold Award.
  Clinical pharmacology and therapeutics 1999 Atkinson AJ, Moore KE, Peck CC
• Treatment of tobacco dependence: innovative regulatory approaches to reduce death and disease: preface.
  Food and drug law journal 1998 Warner KE, Peck CC, Woosley RL, Henningfield JE, Slade J
• Pharmacodynamics of temazepam in primary insomnia: assessment of the value of quantitative electroencephalography and saccadic eye movements in predicting improvement of sleep.
  Clinical pharmacology and therapeutics 1997 Tuk B, Oberyé JJ, Pieters MS, Schoemaker RC, Kemp B, van Gerven J, Danhof M, Kamphuisen HA, Cohen AF, Breimer DD, Peck CC
• Drug development: improving the process.
  Food and drug law journal 1997 Peck CC
• The essential role of integrative biomedical sciences in protecting and contributing to the health and well-being of our nation.
  The Physiologist 1994 Jobe PC, Adams-Curtis LE, Burks TF, Fuller RW, Peck CC, Ruffolo RR, Snead OC, Woosley RL
• Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development.
  Journal of clinical pharmacology 1994 Peck CC, Barr WH, Benet LZ, Collins J, Desjardins RE, Furst DE, Harter JG, Levy G, Ludden T, Rodman JH
• Understanding consequences of concurrent therapies.
  JAMA 1993 Peck CC, Temple R, Collins JM
• Adaptive control with feedback strategies for suramin dosing.
  Clinical pharmacology and therapeutics 1992 Cooper MR, Lieberman R, La Rocca RV, Gernt PR, Weinberger MS, Headlee DJ, Kohler DR, Goldspiel BR, Peck CC, Myers CE
• Dog mastocytoma cells produce transforming growth factor beta 1.
  The Journal of clinical investigation 1992 Pennington DW, Lopez AR, Thomas PS, Peck C, Gold WM
• Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development.
  Journal of pharmaceutical sciences 1992 Peck CC, Barr WH, Benet LZ, Collins J, Desjardins RE, Furst DE, Harter JG, Levy G, Ludden T, Rodman JH
• Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development.
  Pharmaceutical research 1992 Peck CC, Barr WH, Benet LZ, Collins J, Desjardins RE, Furst DE, Harter JG, Levy G, Ludden T, Rodman JH
• Clinical pharmacology training at the Food & Drug Administration.
  Journal of clinical pharmacology 1992 Nelson RC, Peck CC
• Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development.
  Clinical pharmacology and therapeutics 1992 Peck CC, Barr WH, Benet LZ, Collins J, Desjardins RE, Furst DE, Harter JG, Levy G, Ludden T, Rodman JH
• The randomized concentration-controlled trial: an evaluation of its sample size efficiency.
  Controlled clinical trials 1991 Sanathanan LP, Peck CC
• Chronobiology. Suggestions for integrating it into drug development.
  Annals of the New York Academy of Sciences 1991 Harter JG, Peck CC
• FDA regulation of prescription drug advertising.
  JAMA 1990 Peck CC, Rheinstein PH
• FDA's position on the clozaril patient management system.
  Hospital & community psychiatry 1990 Peck CC
• Transcutaneous theophylline collection in preterm infants.
  Clinical pharmacology and therapeutics 1990 Murphy MG, Peck CC, Conner DP, Zamani K, Merenstein GB, Rodden D
• Methodological issues in AIDS clinical trials. Discussion. Design of clinical trials--approaches to clinical trials design.
  Journal of acquired immune deficiency syndromes 1990 Lietman P, Temple R, Harrington M, Peck C
• 'Vasoconstriction'--skin blanching--assay for glucocorticoids--a critique.
  Archives of dermatology 1989 Shah VP, Peck CC, Skelly JP
• Understanding comparisons of drug introductions between the United States and the United Kingdom.
  Clinical pharmacology and therapeutics 1989 Coppinger PL, Peck CC, Temple RJ
• Bayesian regression analysis of non-steady-state phenytoin concentrations: evaluation of predictive performance.
  Therapeutic drug monitoring 1989 Killilea T, Coleman R, Ludden T, Peck CC, Rose D
• Clinical utility of a Bayesian dosing program for phenytoin.
  Therapeutic drug monitoring 1989 Privitera MD, Homan RW, Ludden TM, Peck CC, Vasko MR
• Clinical assessment of a two-compartment Bayesian forecasting method for lidocaine.
  Therapeutic drug monitoring 1988 Beach CL, Farringer JA, Peck CC, Crawford MH, Ludden TM, Clementi WA
• Evaluation of a Bayesian regression-analysis computer program for predicting phenytoin concentration.
  Clinical pharmacy 1986 Ludden TM, Beal SL, Peck CC, Godley PJ
• Current status of clinical pharmacology training in the United States.
  Clinical pharmacology and therapeutics 1986 Peck CC, Crout JR
• Disposition and bioavailability of various formulations of tetrahydrocannabinol in the rhesus monkey.
  Journal of pharmaceutical sciences 1985 Perlin E, Smith CG, Nichols AI, Almirez R, Flora KP, Cradock JC, Peck CC
• Extended least squares nonlinear regression: a possible solution to the "choice of weights" problem in analysis of individual pharmacokinetic data.
  Journal of pharmacokinetics and biopharmaceutics 1984 Peck CC, Beal SL, Sheiner LB, Nichols AI
• The problem of choosing weights in nonlinear regression analysis of pharmacokinetic data.
  Drug metabolism reviews 1984 Peck CC, Sheiner LB, Nichols AI
• Pharmacokinetics and pharmacodynamics of 1,25-dihydroxyvitamin D3 in the chick.
  Endocrinology 1982 Bikle DD, Peck CC, Holford NH, Zolock DT, Morrissey RL
• Normal pharmacokinetics of doxapramin in a patient with renal failure and hypothyroidism.
  British journal of clinical pharmacology 1981 Baker JR, Peck CC, Raybuck BD, Owens EL, Schuster BG
• Improved computer-assisted digoxin therapy. A method using feedback of measured serum digoxin concentrations.
  Annals of internal medicine 1975 Sheiner LB, Halkin H, Peck C, Rosenberg B, Melmon KL
• Determinants of the renal clearance of digoxin.
  Clinical pharmacology and therapeutics 1975 Halkin H, Sheiner LB, Peck CC, Melmon KL
• Differences in serum digoxin concentrations between outpatients and inpatients: an effect of compliance?
  Clinical pharmacology and therapeutics 1974 Sheiner LB, Rosenberg B, Marathe VV, Peck C
• Computer-assisted digoxin therapy.
  The New England journal of medicine 1973 Peck CC, Sheiner LB, Martin CM, Combs DT, Melmon KL