The Role of Pharmacokinetics and Pharmacodynamics in the Development of Biotech Drugs, Pharmacokinetics and pharmacodynamics of biotech drugs, pp.3-13, 2006. ,
DOI : 10.1002/9783527609628.ch1
Guideline on similar biological medicinal products, 2005. ,
The FDA's assessment of follow-on protein products: a historical perspective, Nature Reviews Drug Discovery, vol.24, issue.6 ,
DOI : 10.1038/nrd2307
Statistical Issues in a Modeling Approach to Assessing Bioequivalence or PK Similarity with Presence of Sparsely Sampled Subjects, Journal of Pharmacokinetics and Pharmacodynamics, vol.31, issue.4, pp.321-339, 2004. ,
DOI : 10.1023/B:JOPA.0000042739.44458.e0
Application of the NONMEM Method to Evaluation of the Bioavailability of Drug Products, Journal of Pharmaceutical Sciences, vol.79, issue.12, pp.1116-1120, 1990. ,
DOI : 10.1002/jps.2600791215
Characterization of the highly variable bioavailability of tiludronate in normal volunteers using population pharmacokinetic methodologies, European Journal of Drug Metabolism and Pharmacokinetics, vol.13, issue.3, pp.249-254, 1999. ,
DOI : 10.1007/BF03190028
Bioequivalence: individual and population compartmental modeling compared to the noncompartmental approach, Pharmaceutical Research, vol.13, issue.7, pp.1116-1121, 1996. ,
DOI : 10.1023/A:1016083429903
Unaltered Etanercept Pharmacokinetics With Concurrent Methotrexate in Patients With Rheumatoid Arthritis, The Journal of Clinical Pharmacology, vol.42, issue.4, pp.1235-1243, 2004. ,
DOI : 10.1177/0091270004268049
Bioequivalence Tests Based on Individual Estimates Using Non-compartmental or Model-Based Analyses: Evaluation of Estimates of Sample Means and Type I Error for Different Designs, Pharmaceutical Research, vol.10, issue.1, pp.92-104, 2010. ,
DOI : 10.1007/s11095-009-9980-5
URL : https://hal.archives-ouvertes.fr/inserm-00470343
Model-based analyses of bioequivalence crossover trials using the SAEM algorithm, 2011. ,
Pharmacokinetics and pharmacodynamic data analysis: concepts and applications, 2006. ,
Extension of the SAEM algorithm to leftcensored data in non-linear mixed-effects model: application to HIV dynamics model ,
URL : https://hal.archives-ouvertes.fr/hal-00263506
Statisticians and Pharmacokineticists: What They Can Still Learn From Each Other, Clinical Pharmacology & Therapeutics, vol.170, issue.3, pp.328-334 ,
DOI : 10.1002/sim.2074
Model-based analyses of bioequivalence crossover trials using the SAEM algorithm, Stat Med, 2010. ,
bootstrapping and case-deletion diagnostics in a biologic: a model-based analysis of the effect of formulation differences in a monoclonal antibody, 2008. ,
Estimation of rhG-CSF absorption kinetics after subcutaneous administration using a modified Wagner???Nelson method with a nonlinear elimination model, European Journal of Pharmaceutical Sciences, vol.13, issue.2 ,
DOI : 10.1016/S0928-0987(00)00219-0
Ways to fit a PK model with some data below the quantification limit, Journal of Pharmacokinetics and Pharmacodynamics, vol.28, issue.5, pp.481-504, 2001. ,
DOI : 10.1023/A:1012299115260
Handling Data Below the Limit of Quantification in Mixed Effect Models, The AAPS Journal, vol.11, issue.2, pp.371-380, 2009. ,
DOI : 10.1208/s12248-009-9112-5
Comparison of Model-Based Tests and Selection Strategies to Detect Genetic Polymorphisms Influencing Pharmacokinetic Parameters, Journal of Biopharmaceutical Statistics, vol.5, issue.6, pp.1084-1102, 2008. ,
DOI : 10.1111/j.1525-1438.2006.00593.x
URL : https://hal.archives-ouvertes.fr/inserm-00339183
Convergence of a stochastic approximation version of EM algorithm, Ann Stat, vol.27, pp.94-128, 1999. ,
Coupling a stochastic approximation version of EM with an MCMC procedure, ESAIM: Probability and Statistics, vol.8, pp.115-131, 2004. ,
DOI : 10.1051/ps:2004007
Bioequivalence Studies of Omnitrope, the First Biosimilar/rhGH Follow-on Protein: Two Comparative Phase 1 Randomized Studies and Population Pharmacokinetic Analysis, The Journal of Clinical Pharmacology, vol.36, issue.suppl 1, pp.1339-1348, 2010. ,
DOI : 10.1177/0091270009359005
Pharmacokinetics and pharmacodynamics of erythropoietin receptor in healthy volunteers, Naunyn-Schmiedeberg's Archives of Pharmacology, vol.105, issue.4-6, pp.637-645, 2008. ,
DOI : 10.1007/s00210-007-0225-z
Target-mediated pharmacokinetic and pharmacodynamic model of recombinant human erythropoietin (rHuEPO), Journal of Pharmacokinetics and Pharmacodynamics, vol.29, issue.Suppl 3 ,
DOI : 10.1007/s10928-007-9074-0
Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0, Computer Methods and Programs in Biomedicine, vol.98, issue.1, pp.55-65, 2010. ,
DOI : 10.1016/j.cmpb.2009.09.012
URL : https://hal.archives-ouvertes.fr/inserm-00431457
Theory of optimal experiments, 1972. ,
Design in nonlinear mixed effects models: Optimization using the Fedorov???Wynn algorithm and power of the Wald test for binary covariates, Statistics in Medicine, vol.39, issue.28, pp.5162-5179, 2007. ,
DOI : 10.1002/sim.2910
URL : https://hal.archives-ouvertes.fr/hal-00263513
A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability, Journal of Pharmacokinetics and Biopharmaceutics, vol.12, issue.6, pp.657-680, 1987. ,
DOI : 10.1007/BF01068419
A note on the delta method, Am Stat, vol.46, pp.27-29, 1992. ,
Observed concentrations of somatropin of the complete dataset versus time with their 90% prediction interval (left), and individual weighted residuals (IWRES) versus time (right) for each formulation, reference (top), test T 1 (middle) and test ,