Modeling HIV dynamics and antiviral response with consideration of time-varying drug exposures, adherence and phenotypic sensitivityYANGXIN HUANG; ROSENKRANZ, Susan L; HULIN WU et al.Mathematical biosciences. 2003, Vol 184, Num 2, pp 165-186, issn 0025-5564, 22 p.Article

Simulation of correlated continuous and categorical variables using a single multivariate distributionTANNENBAUM, Stacey J; HOLFORD, Nicholas H. G; LEE, Howard et al.Journal of pharmacokinetics and pharmacodynamics (Print). 2006, Vol 33, Num 6, pp 773-794, issn 1567-567X, 22 p.Article

Modelling and simulation in the development and use of anti-cancer agents : An underused tool?ROMBOUT, Ferdinand; AARONS, Leon; VAN PEER, Achiel et al.Journal of pharmacokinetics and pharmacodynamics (Print). 2004, Vol 31, Num 6, pp 419-440, issn 1567-567X, 22 p.Article

Randomized exposure-controlled trials; impact of randomization and analysis strategiesKARLSSON, Kristin E; GRAHNEN, Anders; KARLSSON, Mats O et al.British journal of clinical pharmacology. 2007, Vol 64, Num 3, pp 266-277, issn 0306-5251, 12 p.Article

The use of clinical trial simulation to support dose selection: Application to development of a new treatment for chronic neuropathic painLOCKWOOD, Peter A; COOK, Jack A; EWY, Wayne E et al.Pharmaceutical research. 2003, Vol 20, Num 11, pp 1752-1759, issn 0724-8741, 8 p.Article

Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect; An example in Alzheimer's diseaseLOCKWOOD, Peter; EWY, Wayne; HERMANN, David et al.Pharmaceutical research. 2006, Vol 23, Num 9, pp 2050-2059, issn 0724-8741, 10 p.Article

Topical Microbicides to Prevent HIV : Clinical Drug Development ChallengesHENDRIX, Craig W; YING JUN CAO; FUCHS, Edward J et al.Annual review of pharmacology and toxicology (Print). 2009, Vol 49, pp 349-375, issn 0362-1642, 27 p.Article

Levodopa slows progression of parkinson's disease. external validation by clinical trial simulationCHAN, Phylinda L. S; NUTT, John G; HOLFORD, Nicholas H. G et al.Pharmaceutical research. 2007, Vol 24, Num 4, pp 791-802, issn 0724-8741, 12 p.Article

Clinical trial simulation using therapeutic effect modeling: Application to ivabradine efficacy in patients with angina pectorisCHABAUD, Sylvie; GIRARD, Pascal; NONY, Patrice et al.Journal of pharmacokinetics and pharmacodynamics (Print). 2002, Vol 29, Num 4, pp 339-363, issn 1567-567X, 25 p.Article

The use of mechanistic DM-PK-PD modelling to assess the power of pharmacogenetic studies : CYP2C9 and warfarin as an exampleDICKINSON, Gemma L; LENNARD, Martin S; TUCKER, Geoffrey T et al.British journal of clinical pharmacology. 2007, Vol 64, Num 1, pp 14-26, issn 0306-5251, 13 p.Article

Power estimation using a population pharmacokinetics model with optimal design by clinical trial simulations: application in pharmacokinetic drug-drug interaction studiesSHUYING YANG; BEERAHEE, Misba.European journal of clinical pharmacology. 2011, Vol 67, Num 3, pp 225-233, issn 0031-6970, 9 p.Article

Survival distributions impact the power of randomized placebo-phase design and parallel groups randomized clinical trialsABRAHAMYANA, Lusine; SILVIA LIA, Chuan; BEYENEA, Joseph et al.Journal of clinical epidemiology. 2011, Vol 64, Num 3, pp 286-292, issn 0895-4356, 7 p.Article

Effect of uncertainty about population parameters on pharmacodynamics-based prediction of clinical trial powerKRAICZI, Holger; FRISEN, Marianne.Contemporary clinical trials. 2005, Vol 26, Num 2, pp 118-130, issn 1551-7144, 13 p.Article

Challenges in implementing adaptive designs : Comments on the viewpoints expressed by regulatory statisticiansGALLO, Paul; MAURER, Willi.Biometrical journal. 2006, Vol 48, Num 4, pp 591-597, issn 0323-3847, 7 p.Article

FDA's critical path initiative : A perspective on contributions of biostatisticsO'NEILL, R. T.Biometrical journal. 2006, Vol 48, Num 4, pp 559-564, issn 0323-3847, 6 p.Article

A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action : Application to clomipramine-lithium interactionGRUWEZ, Bérangère; POIRIER, Marie-France; DAUPHIN, Alain et al.Contemporary clinical trials. 2007, Vol 28, Num 3, pp 276-287, issn 1551-7144, 12 p.Article

Pharmacokinetic/pharmacodynamic models for the depletion of vβ5.2/5.3 T cells by the monoclonal antibody ATM-027 in patients with multiple sclerosis, as measured by FACSZINGMARK, Per-Henrik; EDENIUS, Charlotte; KARLSSON, Mats O et al.British journal of clinical pharmacology. 2004, Vol 58, Num 4, pp 378-389, issn 0306-5251, 12 p.Article

Methodological developments vs. regulatory requirementsBAUER, Peter.Biometrical journal. 2006, Vol 48, Num 4, pp 609-612, issn 0323-3847, 4 p.Article

Design of Long-Term HIV Dynamic Studies Using Semiparametric Mixed-Effects ModelsYANGXIN HUANG; PARK, Jeong-Gun; YILIANG ZHU et al.Biometrical journal. 2008, Vol 50, Num 4, pp 528-540, issn 0323-3847, 13 p.Article

Opening the adaptive toolboxWITTES, Janet; LACHENBRUCH, Peter A.Biometrical journal. 2006, Vol 48, Num 4, pp 598-603, issn 0323-3847, 6 p.Article

Bayesian experimental design for long-term longitudinal HIV dynamic studiesYANGXIN HUANG; HULIN WU.Journal of statistical planning and inference. 2008, Vol 138, Num 1, pp 105-113, issn 0378-3758, 9 p.Conference Paper

Adaptive designs from the viewpoint of an academic biostatisticianSCHÄFER, Helmut.Biometrical journal. 2006, Vol 48, Num 4, pp 586-590, issn 0323-3847, 5 p.Article