Impact of trial design on the estimation of drug potency and power in clinical trials of haemophilia with inhibitors
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[1] N. Kotani,et al. A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A , 2017, Clinical Pharmacokinetics.
[2] F. Leebeek,et al. In silico evaluation of limited blood sampling strategies for individualized recombinant factor IX prophylaxis in hemophilia B patients , 2017, Journal of thrombosis and haemostasis : JTH.
[3] L. Christrup,et al. Analysis of opioid consumption in clinical trials: a simulation based analysis of power of four approaches , 2017, Journal of Pharmacokinetics and Pharmacodynamics.
[4] S. Rasmussen,et al. Repeated Time-to-event Analysis of Consecutive Analgesic Events in Postoperative Pain , 2015, Anesthesiology.
[5] Thomas B. L. Kirkwood,et al. Deciphering death: a commentary on Gompertz (1825) ‘On the nature of the function expressive of the law of human mortality, and on a new mode of determining the value of life contingencies’ , 2015, Philosophical Transactions of the Royal Society B: Biological Sciences.
[6] V. Jiménez‐Yuste,et al. The pharmacokinetics of a B‐domain truncated recombinant factor VIII, turoctocog alfa (NovoEight®), in patients with hemophilia A , 2015, Journal of thrombosis and haemostasis : JTH.
[7] E. Berntorp,et al. Methods for individualising factor VIII dosing in prophylaxis , 2014, European journal of haematology. Supplementum.
[8] Michael Hay,et al. Clinical development success rates for investigational drugs , 2014, Nature Biotechnology.
[9] A. Čeponis,et al. Rapid musculoskeletal ultrasound for painful episodes in adult haemophilia patients , 2013, Haemophilia : the official journal of the World Federation of Hemophilia.
[10] S. Antunes,et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors , 2013, Haemophilia : the official journal of the World Federation of Hemophilia.
[11] P. Giangrande,et al. 40K glycoPEGylated, recombinant FVIIa: 3‐month, double‐blind, randomized trial of safety, pharmacokinetics and preliminary efficacy in hemophilia patients with inhibitors , 2013, Journal of thrombosis and haemostasis : JTH.
[12] R J Keizer,et al. Modeling and Simulation Workbench for NONMEM: Tutorial on Pirana, PsN, and Xpose , 2013, CPT: pharmacometrics & systems pharmacology.
[13] N. Holford. A Time to Event Tutorial for Pharmacometricians , 2013, CPT: pharmacometrics & systems pharmacology.
[14] Erik Berntorp,et al. Clinical trial design in haemophilia , 2012, Haemophilia : the official journal of the World Federation of Hemophilia.
[15] Maria Blettner,et al. On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. , 2012, Deutsches Arzteblatt international.
[16] M. Karlsson,et al. Transient Lower Esophageal Sphincter Relaxation Pharmacokinetic-Pharmacodynamic Modeling: Count Model and Repeated Time-To-Event Model , 2011, Journal of Pharmacology and Experimental Therapeutics.
[17] N. Holford,et al. Clinical Trial Simulation: A Review , 2010, Clinical pharmacology and therapeutics.
[18] S. Björkman. Limited blood sampling for pharmacokinetic dose tailoring of FVIII in the prophylactic treatment of haemophilia A , 2010, Haemophilia : the official journal of the World Federation of Hemophilia.
[19] Mats O. Karlsson,et al. Modelling overdispersion and Markovian features in count data , 2009, Journal of Pharmacokinetics and Pharmacodynamics.
[20] William F Dunn,et al. Simulation for clinical research trials: a theoretical outline. , 2009, Journal of critical care.
[21] A. Shapiro. Anti-hemophilic factor (recombinant), plasma/albumin-free method (octocog-alpha; ADVATE®) in the management of hemophilia A , 2007, Vascular health and risk management.
[22] R. Rossaint,et al. Pharmacokinetics of recombinant activated factor VII in trauma patients with severe bleeding , 2006, Critical care.
[23] Mats O. Karlsson,et al. Evaluation of Type I Error Rates When Modeling Ordered Categorical Data in NONMEM , 2004, Journal of Pharmacokinetics and Pharmacodynamics.
[24] K. Pasi,et al. Haemophilias A and B , 2003, The Lancet.
[25] Mats O. Karlsson,et al. Assessment of Type I Error Rates for the Statistical Sub-model in NONMEM , 2002, Journal of Pharmacokinetics and Pharmacodynamics.
[26] Mats O. Karlsson,et al. Assessment of Actual Significance Levels for Covariate Effects in NONMEM , 2001, Journal of Pharmacokinetics and Pharmacodynamics.
[27] Lewis B. Sheiner,et al. A Population Pharmacokinetic–Pharmacodynamic Analysis of Repeated Measures Time-to-Event Pharmacodynamic Responses: The Antiemetic Effect of Ondansetron , 1999, Journal of Pharmacokinetics and Biopharmaceutics.
[28] D J Sargent,et al. A general framework for random effects survival analysis in the Cox proportional hazards setting. , 1998, Biometrics.
[29] K. Land,et al. A Comparison of Poisson, Negative Binomial, and Semiparametric Mixed Poisson Regression Models , 1996 .
[30] S. Shapiro,et al. Efficacy of prothrombin-complex concentrates in hemophiliacs with antibodies to factor VIII: a multicenter therapeutic trial. , 1980, The New England journal of medicine.
[31] M. Ozelo,et al. Key issues in inhibitor management in patients with haemophilia. , 2014, Blood transfusion = Trasfusione del sangue.
[32] L. Haan,et al. Extreme value theory : an introduction , 2006 .
[33] C. H. Evans,et al. Small Clinical Trials: Issues and Challenges , 2001 .