Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group

[1]  T. Bouillon,et al.  Pharmacokinetic interactions among imatinib, bosentan and sildenafil, and their clinical implications in severe pulmonary arterial hypertension. , 2015, British journal of clinical pharmacology.

[2]  Ping Zhao,et al.  Dealing with the complex drug-drug interactions: towards mechanistic models. , 2015, Biopharmaceutics & drug disposition.

[3]  M. Hutmacher,et al.  Covariate selection in pharmacometric analyses: a review of methods , 2015, British journal of clinical pharmacology.

[4]  Justin C. Earp,et al.  Utility of population pharmacokinetic modeling in the assessment of therapeutic protein‐drug interactions , 2014, Journal of clinical pharmacology.

[5]  P Chan,et al.  Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance , 2013, CPT: pharmacometrics & systems pharmacology.

[6]  P. Neuvonen,et al.  A Semiphysiological Population Pharmacokinetic Model for Dynamic Inhibition of Liver and Gut Wall Cytochrome P450 3A by Voriconazole , 2013, Clinical Pharmacokinetics.

[7]  Shuying Yang,et al.  Power estimation using a population pharmacokinetics model with optimal design by clinical trial simulations: application in pharmacokinetic drug–drug interaction studies , 2011, European Journal of Clinical Pharmacology.

[8]  Isabelle Ragueneau-Majlessi,et al.  A useful tool for drug interaction evaluation: The University of Washington Metabolism and Transport Drug Interaction Database , 2010, Human Genomics.

[9]  Hans Guenter Schaefer,et al.  Semi-Mechanistic Population Pharmacokinetic Drug-Drug Interaction Modelling of a Long Half-Life Substrate and Itraconazole , 2010, Clinical pharmacokinetics.

[10]  Amin Rostami-Hodjegan,et al.  Assessing the efficiency of mixed effects modelling in quantifying metabolism based drug–drug interactions: using in vitro data as an aid to assess study power , 2009, Pharmaceutical statistics.

[11]  Anika Ashok,et al.  Guidance for Industry by U.S. Department of Health and Human Services—Food and Drug Administration—Center for Biologics Evaluation and Research (CBER)—February 1999 , 2009 .

[12]  J. Abraham The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[13]  P. Vichyanond,et al.  The utility of the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) system for the assessment of adverse drug reactions in hospitalized children. , 2008, Asian Pacific journal of allergy and immunology.

[14]  K. Cohen,et al.  Population pharmacokinetics of nevirapine in combination with rifampicin-based short course chemotherapy in HIV- and tuberculosis-infected South African patients , 2008, European Journal of Clinical Pharmacology.

[15]  A. Li Drug–Drug Interactions in Pharmaceutical Development , 2007 .

[16]  Xh Huang,et al.  Pharmacokinetic-Pharmacodynamic Modeling and Simulation. , 2007 .

[17]  E. Ludwig,et al.  Population Pharmacokinetics of Risperidone and 9-Hydroxyrisperidone in Patients with Acute Episodes Associated with Bipolar I Disorder , 2007, Journal of Pharmacokinetics and Pharmacodynamics.

[18]  Honghui Zhou,et al.  Population‐Based Assessments of Clinical Drug‐Drug Interactions: Qualitative Indices or Quantitative Measures? , 2006, Journal of clinical pharmacology.

[19]  A. Racine‐Poon,et al.  Population pharmacokinetics of imatinib mesylate in patients with chronic-phase chronic myeloid leukaemia: results of a phase III study. , 2005, British journal of clinical pharmacology.

[20]  P. Klein,et al.  Population pharmacokinetics of trastuzumab in patients With HER2+ metastatic breast cancer , 2005, Cancer Chemotherapy and Pharmacology.

[21]  Lewis B. Sheiner,et al.  Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: Routine clinical pharmacokinetic data , 1983, Journal of Pharmacokinetics and Biopharmaceutics.

[22]  Lewis B. Sheiner,et al.  Evaluation of methods for estimating population pharmacokinetic parameters II. Biexponential model and experimental pharmacokinetic data , 1981, Journal of Pharmacokinetics and Biopharmaceutics.

[23]  Lewis B. Sheiner,et al.  Evaluation of methods for estimating population pharmacokinetic parameters. I. Michaelis-menten model: Routine clinical pharmacokinetic data , 1980, Journal of Pharmacokinetics and Biopharmaceutics.

[24]  L. Aarons,et al.  Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years. , 2003, British journal of clinical pharmacology.

[25]  Thomas M. Ludden,et al.  Estimation of Population Pharmacokinetic Parameters in the Presence of Non-compliance , 2003, Journal of Pharmacokinetics and Pharmacodynamics.

[26]  Peter I D Lee,et al.  Design and Power of A Population Pharmacokinetic Study , 2004, Pharmaceutical Research.

[27]  Mats O Karlsson,et al.  Population pharmacokinetics of clomethiazole and its effect on the natural course of sedation in acute stroke patients. , 2003, British journal of clinical pharmacology.

[28]  C. Flexner,et al.  Model-based analysis of the pharmacokinetic interactions between ritonavir, nelfinavir, and saquinavir after simultaneous and staggered oral administration. , 2002, Drug metabolism and disposition: the biological fate of chemicals.

[29]  K G Kowalski,et al.  Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study. , 2001, Statistics in medicine.

[30]  J. Steimer,et al.  Population pharmacokinetics of levodopa in patients with Parkinson's disease treated with tolcapone , 2000, Clinical pharmacology and therapeutics.

[31]  J. Verweij,et al.  Population Pharmacokinetics/Toxicodynamics (PK/TD) Relationship of SAM486A in Phase I Studies in Patients with Advanced Cancers , 2000, Journal of clinical pharmacology.

[32]  J. Steimer,et al.  Population pharmacokinetics of tolcapone in parkinsonian patients in dose finding studies. , 2000, British journal of clinical pharmacology.

[33]  B Vrijens,et al.  The impact of compliance in pharmacokinetic studies , 1999, Statistical methods in medical research.

[34]  R B Smith,et al.  An evaluation of population pharmacokinetics in therapeutic trials. Part II. Detection of a drug‐drug interaction , 1987, Clinical pharmacology and therapeutics.