-
1
-
-
84861192469
-
-
FDA. Guidance for industry: statistical aproaches to establishing bioequivalence, Technical Report, FDA
-
FDA. Guidance for industry: statistical aproaches to establishing bioequivalence, Technical Report, FDA, 2001.
-
(2001)
-
-
-
2
-
-
84861192468
-
-
EMEA. Note for guidance on the investigation of bioavailability and bioequivalence, Technical Report, EMEA
-
EMEA. Note for guidance on the investigation of bioavailability and bioequivalence, Technical Report, EMEA, 2001.
-
(2001)
-
-
-
5
-
-
84861196080
-
-
Estimation and significant tests of area under the curve derived from incomplete blood sampling. American statistical association proceedings of the biopharmaceutical section
-
Yeh C. Estimation and significant tests of area under the curve derived from incomplete blood sampling. American statistical association proceedings of the biopharmaceutical section, 1990;74-81.
-
(1990)
, pp. 74-81
-
-
Yeh, C.1
-
6
-
-
77749311489
-
A theoretical framework for estimation of aucs in complete and incomplete sampling designs
-
DOI: 10.1198/sbr.2009.0025.
-
Jaki T, Wolfsegger MJ.A theoretical framework for estimation of aucs in complete and incomplete sampling designs. Statistics in Biopharmaceutical Research 2009;1:176-184. DOI: 10.1198/sbr.2009.0025.
-
(2009)
Statistics in Biopharmaceutical Research
, vol.1
, pp. 176-184
-
-
Jaki, T.1
Wolfsegger, M.J.2
-
9
-
-
0035067331
-
Estimation of rhG-CSF absorption kinetics after subcutaneous administration using a modified Wagner-Nelson method with a nonlinear elimination model
-
DOI: 10.1016/S0928-0987(00)00219-0.
-
Hayashi N, Aso H, Higashida M, Kinoshita H, Ohdo S, Yukawa E, Hiquchi S. 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 2001;13:151-158. DOI: 10.1016/S0928-0987(00)00219-0.
-
(2001)
European Journal of Pharmaceutical Sciences
, vol.13
, pp. 151-158
-
-
Hayashi, N.1
Aso, H.2
Higashida, M.3
Kinoshita, H.4
Ohdo, S.5
Yukawa, E.6
Hiquchi, S.7
-
10
-
-
0015405814
-
Modelling of individual pharmacokinetics for computer-aided drug dosage
-
DOI: 10.1016/0010-4809(72)90051-1.
-
Sheiner LB, Rosenberg B, Melmon KL. Modelling of individual pharmacokinetics for computer-aided drug dosage. Computers and Biomedical Research 1972;5:411-459. DOI: 10.1016/0010-4809(72)90051-1.
-
(1972)
Computers and Biomedical Research
, vol.5
, pp. 411-459
-
-
Sheiner, L.B.1
Rosenberg, B.2
Melmon, K.L.3
-
11
-
-
0034119297
-
Pharmacokinetic/pharmacodynamic modelling in drug development
-
DOI: 10.1146/annurev.pharmtox.40.1.67.
-
Sheiner LB, Steimer JL. Pharmacokinetic/pharmacodynamic modelling in drug development. Annual Review of Pharmacology and Toxicology 2000;40:67-95. DOI: 10.1146/annurev.pharmtox.40.1.67.
-
(2000)
Annual Review of Pharmacology and Toxicology
, vol.40
, pp. 67-95
-
-
Sheiner, L.B.1
Steimer, J.L.2
-
12
-
-
33847741777
-
Impact of modeling intra-subject variability on tests based on non-linear mixed-effects models in cross-over pharmacokinetic trials with application to the interaction of tenofovir on atazanavir in HIV patients
-
DOI: 10.1002/sim.2622.
-
Panhard X, Taburet AM, Piketti C, Mentré F. Impact of modeling intra-subject variability on tests based on non-linear mixed-effects models in cross-over pharmacokinetic trials with application to the interaction of tenofovir on atazanavir in HIV patients. Statistics in Medicine 2007;26:1268-1284. DOI: 10.1002/sim.2622.
-
(2007)
Statistics in Medicine
, vol.26
, pp. 1268-1284
-
-
Panhard, X.1
Taburet, A.M.2
Piketti, C.3
Mentré, F.4
-
13
-
-
72949115498
-
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
-
DOI: 10.1007/s11095-009-9980-5.
-
Dubois A, Gsteiger S, Pigeolet E, Mentré F. 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 2010;27:92-110. DOI: 10.1007/s11095-009-9980-5.
-
(2010)
Pharmaceutical Research
, vol.27
, pp. 92-110
-
-
Dubois, A.1
Gsteiger, S.2
Pigeolet, E.3
Mentré, F.4
-
14
-
-
80051877714
-
Model-based analyses of bioequivalence crossover trials using the stochastic approximation expectation maximisation algorithm
-
DOI: 10.1002/sim.4286.
-
Dubois A, Lavielle M, Gsteiger S, Pigeolet E, Mentré F. Model-based analyses of bioequivalence crossover trials using the stochastic approximation expectation maximisation algorithm. Statistics in Medicine 2011;30:2582-2600. DOI: 10.1002/sim.4286.
-
(2011)
Statistics in Medicine
, vol.30
, pp. 2582-2600
-
-
Dubois, A.1
Lavielle, M.2
Gsteiger, S.3
Pigeolet, E.4
Mentré, F.5
-
15
-
-
0025081107
-
Experimental design and efficient parameter estimation in population pharmacokinetics
-
DOI: 10.1007/BF01062273.
-
Al-Banna MK, Kelman AW, Whiting B. Experimental design and efficient parameter estimation in population pharmacokinetics. Journal of Pharmacokinetics and Biopharmaceutics 1990;18:347-360. DOI: 10.1007/BF01062273.
-
(1990)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.18
, pp. 347-360
-
-
Al-Banna, M.K.1
Kelman, A.W.2
Whiting, B.3
-
16
-
-
0026095849
-
Designs for population pharmacodynamics: value of pharmacokinetic data and population analysis
-
DOI: 10.1007/BF03036255.
-
Hashimoto Y, Sheiner LB. Designs for population pharmacodynamics: value of pharmacokinetic data and population analysis. Journal of Pharmacokinetics and Biopharmaceutics 1991'19:333-353. DOI: 10.1007/BF03036255.
-
(1991)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.19
, pp. 333-353
-
-
Hashimoto, Y.1
Sheiner, L.B.2
-
17
-
-
0029776497
-
Comparison of some practical sampling strategies for population pharmacokinetic studies
-
DOI: 10.1007/BF02353491.
-
Jonsson EN, Wade JR, Karlsson MO. Comparison of some practical sampling strategies for population pharmacokinetic studies. Journal of Pharmacokinetics and Biopharmaceutics 1996;24:245-263. DOI: 10.1007/BF02353491.
-
(1996)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.24
, pp. 245-263
-
-
Jonsson, E.N.1
Wade, J.R.2
Karlsson, M.O.3
-
20
-
-
0000963178
-
Optimal design in random effect regression models
-
DOI: 10.1093/biomet/84.2.429.
-
Mentré F, Mallet A, Baccar D. Optimal design in random effect regression models. Biometrika 1997;84:429-442. DOI: 10.1093/biomet/84.2.429.
-
(1997)
Biometrika
, vol.84
, pp. 429-442
-
-
Mentré, F.1
Mallet, A.2
Baccar, D.3
-
21
-
-
77950369264
-
Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0
-
DOI: 10.1016/j.cmpb.2009.09.012.
-
Bazzoli C, Retout S, Mentré F. Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0. Computer Methods and Programs in Biomedicine 2010;98:55-65. DOI: 10.1016/j.cmpb.2009.09.012.
-
(2010)
Computer Methods and Programs in Biomedicine
, vol.98
, pp. 55-65
-
-
Bazzoli, C.1
Retout, S.2
Mentré, F.3
-
22
-
-
33747140841
-
Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments
-
DOI: 10.1208/aapsj070476.
-
Hooker A, Vicini P. Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments. American Association of Pharmaceutical Scientists Journal 2005;7:759-785. DOI: 10.1208/aapsj070476.
-
(2005)
American Association of Pharmaceutical Scientists Journal
, vol.7
, pp. 759-785
-
-
Hooker, A.1
Vicini, P.2
-
23
-
-
33645817934
-
Optimal design for multivariate response pharmacokinetic models
-
DOI: 10.1007/s10928-006-9009-1.
-
Gueorguieva I, Aarons L, Ogungbenro K, Jorga KM, Rodgers T, Rowland M. Optimal design for multivariate response pharmacokinetic models. Journal of Pharmacokinetics and Pharmacodynamics 2006;33:97-124. DOI: 10.1007/s10928-006-9009-1.
-
(2006)
Journal of Pharmacokinetics and Pharmacodynamics
, vol.33
, pp. 97-124
-
-
Gueorguieva, I.1
Aarons, L.2
Ogungbenro, K.3
Jorga, K.M.4
Rodgers, T.5
Rowland, M.6
-
24
-
-
34249912369
-
Optimal design for multiresponse pharmacokinetic-pharmacodynamic models-dealing with unbalanced designs
-
DOI: 10.1007/s10928-006-9048-7.
-
Ogungbenro K, Gueorguieva I, Majid O, Graham G, Aarons L. Optimal design for multiresponse pharmacokinetic-pharmacodynamic models-dealing with unbalanced designs. Journal of Pharmacokinetics and Pharmacodynamics 2007;34:313-331. DOI: 10.1007/s10928-006-9048-7.
-
(2007)
Journal of Pharmacokinetics and Pharmacodynamics
, vol.34
, pp. 313-331
-
-
Ogungbenro, K.1
Gueorguieva, I.2
Majid, O.3
Graham, G.4
Aarons, L.5
-
25
-
-
40449086351
-
Incorporating correlation in interindividual variability for the optimal design of multiresponse pharmacokinetic experiments
-
DOI: 10.1080/10543400701697208.
-
Ogungbenro K, Graham G, Gueorguieva I, Aarons L. Incorporating correlation in interindividual variability for the optimal design of multiresponse pharmacokinetic experiments. Journal of Biopharmaceutical Statistics 2008;18:342-358. DOI: 10.1080/10543400701697208.
-
(2008)
Journal of Biopharmaceutical Statistics
, vol.18
, pp. 342-358
-
-
Ogungbenro, K.1
Graham, G.2
Gueorguieva, I.3
Aarons, L.4
-
26
-
-
69949092783
-
Fisher information matrix for nonlinear mixed effects multiple response models: evaluation of the appropriateness of the first order linearization using a pharmacokinetic/pharmacodynamic model
-
DOI: 10.1002/sim.3573.
-
Bazzoli C, Retout S, Mentré F. Fisher information matrix for nonlinear mixed effects multiple response models: evaluation of the appropriateness of the first order linearization using a pharmacokinetic/pharmacodynamic model. Statistics in Medicine 2009;28:1940-1956. DOI: 10.1002/sim.3573.
-
(2009)
Statistics in Medicine
, vol.28
, pp. 1940-1956
-
-
Bazzoli, C.1
Retout, S.2
Mentré, F.3
-
27
-
-
84861192757
-
-
Software for optimal design in population pharmacokinetics and pharmacodynamics: a comparison. 16th Population Approach Group in Europe. Copenhagen, Denmark, Abstract 1179.
-
Mentré F, Duffull S, Gueorguieva I, Hooker A, Leonov S, Ogungbenro K, Retout S. Software for optimal design in population pharmacokinetics and pharmacodynamics: a comparison. 16th Population Approach Group in Europe. Copenhagen, Denmark, 2007. Abstract 1179.
-
(2007)
-
-
Mentré, F.1
Duffull, S.2
Gueorguieva, I.3
Hooker, A.4
Leonov, S.5
Ogungbenro, K.6
Retout, S.7
-
28
-
-
0027715858
-
The importance of modelling the inter-occasion variability in population pharmacokinetic studies
-
DOI: 10.1007/BF01113502.
-
Karlsson MO, Sheiner LB. The importance of modelling the inter-occasion variability in population pharmacokinetic studies. Journal of Pharmacokinetics and Biopharmaceutics 1993;21:735-750. DOI: 10.1007/BF01113502.
-
(1993)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.21
, pp. 735-750
-
-
Karlsson, M.O.1
Sheiner, L.B.2
-
29
-
-
0037278847
-
Further developments of the Fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics
-
DOI: 10.1081/BIP-120019267.
-
Retout S, Mentré F. Further developments of the Fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics. Journal of Biopharmaceutical Statistics 2003;13:209-227. DOI: 10.1081/BIP-120019267.
-
(2003)
Journal of Biopharmaceutical Statistics
, vol.13
, pp. 209-227
-
-
Retout, S.1
Mentré, F.2
-
30
-
-
36349024782
-
Design in nonlinear mixed effects models: optimisation using the Fedorov-Wynn algorithm and power of the wald test for binary covariates
-
DOI: 10.1002/sim.2910.
-
Retout S, Comets E, Samson A, Mentré F. Design in nonlinear mixed effects models: optimisation using the Fedorov-Wynn algorithm and power of the wald test for binary covariates. Statistics in Medicine 2007;26:5162-5179. DOI: 10.1002/sim.2910.
-
(2007)
Statistics in Medicine
, vol.26
, pp. 5162-5179
-
-
Retout, S.1
Comets, E.2
Samson, A.3
Mentré, F.4
-
31
-
-
84861192961
-
-
Some considerations on the Fisher information in nonlinear mixed effects models. Proceedings of the 9th international workshop in model-oriented design and analysis, Bertinoro, Italy,.
-
Mielke T, Schwabe R. Some considerations on the Fisher information in nonlinear mixed effects models. Proceedings of the 9th international workshop in model-oriented design and analysis, Bertinoro, Italy, 2010.
-
(2010)
-
-
Mielke, T.1
Schwabe, R.2
-
32
-
-
19144365774
-
Evaluation by simulation of tests based on non-linear mixed effects models in pharmacokinetic interaction and bioequivalence cross-over trials
-
DOI: 10.1002/sim.2047.
-
Panhard X, Mentré F. Evaluation by simulation of tests based on non-linear mixed effects models in pharmacokinetic interaction and bioequivalence cross-over trials. Statistics in Medicine 2005;24:1509-1524. DOI: 10.1002/sim.2047.
-
(2005)
Statistics in Medicine
, vol.24
, pp. 1509-1524
-
-
Panhard, X.1
Mentré, F.2
-
33
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
-
DOI: 10.1007/BF01068419.
-
Schuirmann DJ.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 1987;15:657-680. DOI: 10.1007/BF01068419.
-
(1987)
Journal of Pharmacokinetics and Biopharmaceutics
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
35
-
-
0000558035
-
Results in the theory and construction of D-optimum designs
-
Wynn HP. Results in the theory and construction of D-optimum designs. Journal of the Royal Statistical Society B 1972;34:133-147.
-
(1972)
Journal of the Royal Statistical Society B
, vol.34
, pp. 133-147
-
-
Wynn, H.P.1
-
36
-
-
0033243858
-
Convergence of a stochastic approximation version of EM algorithm
-
DOI: 10.1214/aos/1018031103.
-
Delyon B, Lavielle M, Moulines E. Convergence of a stochastic approximation version of EM algorithm. The Annals of Statistics 1999;27:94-128. DOI: 10.1214/aos/1018031103.
-
(1999)
The Annals of Statistics
, vol.27
, pp. 94-128
-
-
Delyon, B.1
Lavielle, M.2
Moulines, E.3
-
37
-
-
19044400906
-
Maximum likelihood estimation in nonlinear mixed effects model
-
DOI: 10.1016/j.csda.2004.07.002.
-
Kuhn E, Lavielle M. Maximum likelihood estimation in nonlinear mixed effects model. Computational Statistics and Data Analysis 2004;49:1020-1038. DOI: 10.1016/j.csda.2004.07.002.
-
(2004)
Computational Statistics and Data Analysis
, vol.49
, pp. 1020-1038
-
-
Kuhn, E.1
Lavielle, M.2
-
38
-
-
35948944562
-
The SAEM algorithm for group comparison tests in longitudinal data analysis based on non-linear mixed effects model
-
DOI: 10.1002/sim.2950.
-
Samson A, Lavielle M, Mentré F. The SAEM algorithm for group comparison tests in longitudinal data analysis based on non-linear mixed effects model. Statistics in Medecine 2007;26:4860-4875. DOI: 10.1002/sim.2950.
-
(2007)
Statistics in Medecine
, vol.26
, pp. 4860-4875
-
-
Samson, A.1
Lavielle, M.2
Mentré, F.3
-
39
-
-
57749092099
-
Extension of the SAEM algorithm for nonlinear mixed effects models with two levels of random effects
-
DOI: 10.1093/biostatistics/kxn020.
-
Panhard X, Samson A. Extension of the SAEM algorithm for nonlinear mixed effects models with two levels of random effects. Biostatistics 2009;10:121-135. DOI: 10.1093/biostatistics/kxn020.
-
(2009)
Biostatistics
, vol.10
, pp. 121-135
-
-
Panhard, X.1
Samson, A.2
-
40
-
-
33750740728
-
Extension of the SAEM algorithm to left-censored data in nonlinear mixed-effects model: application to HIV dynamics model
-
DOI: 10.1016/j.csda.2006.05.007.
-
Samson A, Lavielle M, Mentré F. Extension of the SAEM algorithm to left-censored data in nonlinear mixed-effects model: application to HIV dynamics model. Computational Statistics and Data Analysis 2006;51:1562-1574. DOI: 10.1016/j.csda.2006.05.007.
-
(2006)
Computational Statistics and Data Analysis
, vol.51
, pp. 1562-1574
-
-
Samson, A.1
Lavielle, M.2
Mentré, F.3
-
41
-
-
12344327791
-
Optimal population designs for PK models with serial sampling
-
DOI: 10.1081/BIP-200040853.
-
Gagnon R, Leonov S. Optimal population designs for PK models with serial sampling. Journal of Biopharmaceutical Statistics 2005;15:143-163. DOI: 10.1081/BIP-200040853.
-
(2005)
Journal of Biopharmaceutical Statistics
, vol.15
, pp. 143-163
-
-
Gagnon, R.1
Leonov, S.2
-
42
-
-
79954595958
-
Design evaluation and optimisation for models of hepatitis C viral dynamics
-
DOI: 10.1002/sim.4191.
-
Guedj J, Bazzoli C, Neumann AU, Mentré F. Design evaluation and optimisation for models of hepatitis C viral dynamics. Statistics in Medicine 2011;30:1045-1056. DOI: 10.1002/sim.4191.
-
(2011)
Statistics in Medicine
, vol.30
, pp. 1045-1056
-
-
Guedj, J.1
Bazzoli, C.2
Neumann, A.U.3
Mentré, F.4
|