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Methods for non-proportional hazards in clinical trials: A systematic review.
- Published in:
- Statistical Methods in Medical Research, 2024, v. 33, n. 6, p. 1069, doi. 10.1177/09622802241242325
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- Publication type:
- Article
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.
- Published in:
- AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00897-8
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- Publication type:
- Article
Optimizing the design of a pharmacokinetic trial to evaluate the dosing scheme of a novel tuberculosis drug in children living with or without HIV.
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- CPT: Pharmacometrics & Systems Pharmacology, 2024, v. 13, n. 2, p. 270, doi. 10.1002/psp4.13077
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- Article
Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials.
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- Orphanet Journal of Rare Diseases, 2023, v. 18, n. 1, p. 1, doi. 10.1186/s13023-023-02990-1
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- Publication type:
- Article
How to analyze continuous and discrete repeated measures in small‐sample cross‐over trials?
- Published in:
- Biometrics, 2023, v. 79, n. 4, p. 3998, doi. 10.1111/biom.13920
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- Publication type:
- Article
Generation and application of avatars in pharmacometric modelling.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2023, v. 50, n. 5, p. 411, doi. 10.1007/s10928-023-09873-9
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- Publication type:
- Article
Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop.
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- CPT: Pharmacometrics & Systems Pharmacology, 2023, v. 12, n. 5, p. 624, doi. 10.1002/psp4.12931
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- Publication type:
- Article
The manufacturing of 3D-printed microfluidic chips to analyse the effect upon particle size during the synthesis of lipid nanoparticles.
- Published in:
- Journal of Pharmacy & Pharmacology, 2023, v. 75, n. 2, p. 245, doi. 10.1093/jpp/rgac085
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- Publication type:
- Article
Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization.
- Published in:
- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 12, p. 1452, doi. 10.1002/psp4.12713
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- Article
Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence.
- Published in:
- Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1190, doi. 10.1002/cpt.2120
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- Article
Metaheuristics for pharmacometrics.
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- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 11, p. 1297, doi. 10.1002/psp4.12714
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- Publication type:
- Article
Pharmacometrics meets statistics—A synergy for modern drug development.
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- CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 10, p. 1134, doi. 10.1002/psp4.12696
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- Publication type:
- Article
The Present and Future Role of Microfluidics for Protein and Peptide-Based Therapeutics and Diagnostics.
- Published in:
- Applied Sciences (2076-3417), 2021, v. 11, n. 9, p. 4109, doi. 10.3390/app11094109
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- Publication type:
- Article
Bounded Integer Modeling of Symptom Scales Specific to Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
- Published in:
- AAPS Journal, 2021, v. 23, n. 2, p. 1, doi. 10.1208/s12248-021-00568-y
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- Publication type:
- Article
Model‐Informed Drug Development for Long‐Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium.
- Published in:
- Clinical Pharmacology in Drug Development, 2021, v. 10, n. 3, p. 220, doi. 10.1002/cpdd.928
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- Publication type:
- Article
Integrated Item Response Theory Modeling of Multiple Patient-Reported Outcomes Assessing Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00484-7
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- Publication type:
- Article
Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.
- Published in:
- AAPS Journal, 2020, v. 22, n. 5, p. N.PAG, doi. 10.1208/s12248-020-00500-w
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- Publication type:
- Article
Saddle-Reset for Robust Parameter Estimation and Identifiability Analysis of Nonlinear Mixed Effects Models.
- Published in:
- AAPS Journal, 2020, v. 22, n. 4, p. 1, doi. 10.1208/s12248-020-00471-y
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- Publication type:
- Article
Optimizing Dose-Finding Studies for Drug Combinations Based on Exposure-Response Models.
- Published in:
- AAPS Journal, 2019, v. 21, n. 5, p. N.PAG, doi. 10.1208/s12248-019-0365-3
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- Publication type:
- Article
A Population Pharmacokinetic-Pharmacodynamic Model of Pegfilgrastim.
- Published in:
- AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0249-y
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- Publication type:
- Article
Implementing Optimal Designs for Dose-Response Studies Through Adaptive Randomization for a Small Population Group.
- Published in:
- AAPS Journal, 2018, v. 20, n. 5, p. 1, doi. 10.1208/s12248-018-0242-5
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- Publication type:
- Article
The Standard Output: A Tool‐Agnostic Modeling Storage Format.
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- CPT: Pharmacometrics & Systems Pharmacology, 2018, v. 7, n. 9, p. 543, doi. 10.1002/psp4.12339
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- Publication type:
- Article
Model‐Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.
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- 2018
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- Publication type:
- Proceeding
Feasibility of Exposure-Response Analyses for Clinical Dose-Ranging Studies of Drug Combinations.
- Published in:
- AAPS Journal, 2018, v. 20, n. 3, p. 1, doi. 10.1208/s12248-018-0226-5
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- Publication type:
- Article
Correction to: Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology.
- Published in:
- AAPS Journal, 2018, v. 20, n. 3, p. 1, doi. 10.1208/s12248-018-0218-5
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- Publication type:
- Article
Model-Based Adaptive Optimal Design (MBAOD) Improves Combination Dose Finding Designs: an Example in Oncology.
- Published in:
- AAPS Journal, 2018, v. 20, n. 2, p. 1, doi. 10.1208/s12248-018-0206-9
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- Publication type:
- Article
Adaptive Optimal Designs for Dose-Finding Studies with Time-to-Event Outcomes.
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- AAPS Journal, 2018, v. 20, n. 1, p. 1, doi. 10.1208/s12248-017-0166-5
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- Publication type:
- Article
Model selection and averaging of nonlinear mixed-effect models for robust phase III dose selection.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2017, v. 44, n. 6, p. 581, doi. 10.1007/s10928-017-9550-0
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- Publication type:
- Article
Assessing robustness of designs for random effects parameters for nonlinear mixed-effects models.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2017, v. 44, n. 6, p. 611, doi. 10.1007/s10928-017-9552-y
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- Publication type:
- Article
Model Description Language (MDL): A Standard for Modeling and Simulation.
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- CPT: Pharmacometrics & Systems Pharmacology, 2017, v. 6, n. 10, p. 647, doi. 10.1002/psp4.12222
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- Publication type:
- Article
The effect of using a robust optimality criterion in model based adaptive optimization.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2017, v. 44, n. 4, p. 317, doi. 10.1007/s10928-017-9521-5
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- Publication type:
- Article
Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials.
- Published in:
- Pharmaceutical Research, 2017, v. 34, n. 5, p. 1125, doi. 10.1007/s11095-017-2122-6
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- Publication type:
- Article
The effect of Fisher information matrix approximation methods in population optimal design calculations.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2016, v. 43, n. 6, p. 609, doi. 10.1007/s10928-016-9499-4
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- Publication type:
- Article
Accelerating Monte Carlo power studies through parametric power estimation.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2016, v. 43, n. 2, p. 223, doi. 10.1007/s10928-016-9468-y
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- Publication type:
- Article
Preconditioning of Nonlinear Mixed Effects Models for Stabilisation of Variance-Covariance Matrix Computations.
- Published in:
- AAPS Journal, 2016, v. 18, n. 2, p. 505, doi. 10.1208/s12248-016-9866-5
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- Publication type:
- Article
Estimation of drug receptor occupancy when non-displaceable binding differs between brain regions - extending the simplified reference tissue model.
- Published in:
- British Journal of Clinical Pharmacology, 2015, v. 80, n. 1, p. 116, doi. 10.1111/bcp.12558
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- Publication type:
- Article
Improved precision of exposure-response relationships by optimal dose-selection. Examples from studies of receptor occupancy using PET and dose finding for neuropathic pain treatment.
- Published in:
- Journal of Pharmacokinetics & Pharmacodynamics, 2015, v. 42, n. 3, p. 211, doi. 10.1007/s10928-015-9410-8
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- Publication type:
- Article
Methods and software tools for design evaluation in population pharmacokinetics-pharmacodynamics studies.
- Published in:
- British Journal of Clinical Pharmacology, 2015, v. 79, n. 1, p. 6, doi. 10.1111/bcp.12352
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- Publication type:
- Article
Optimal clinical trial design based on a dichotomous Markov-chain mixed-effect sleep model.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2014, v. 41, n. 6, p. 639, doi. 10.1007/s10928-014-9391-z
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- Publication type:
- Article
Improved Utilization of ADAS-Cog Assessment Data Through Item Response Theory Based Pharmacometric Modeling.
- Published in:
- Pharmaceutical Research, 2014, v. 31, n. 8, p. 2152, doi. 10.1007/s11095-014-1315-5
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- Publication type:
- Article
Evaluation of bias, precision, robustness and runtime for estimation methods in NONMEM 7.
- Published in:
- Journal of Pharmacokinetics & Pharmacodynamics, 2014, v. 41, n. 3, p. 223, doi. 10.1007/s10928-014-9359-z
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- Publication type:
- Article
Simultaneous optimal experimental design for in vitro binding parameter estimation.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2013, v. 40, n. 5, p. 573, doi. 10.1007/s10928-013-9330-4
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- Publication type:
- Article
Optimizing disease progression study designs for drug effect discrimination.
- Published in:
- Journal of Pharmacokinetics & Pharmacodynamics, 2013, v. 40, n. 5, p. 587, doi. 10.1007/s10928-013-9331-3
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- Publication type:
- Article
Plasma and Cerebrospinal Fluid Pharmacokinetics of Naproxen in Children.
- Published in:
- Journal of Clinical Pharmacology, 2012, v. 52, n. 10, p. 1516, doi. 10.1177/0091270011418658
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- Publication type:
- Article
Serial correlation in optimal design for nonlinear mixed effects models.
- Published in:
- Journal of Pharmacokinetics & Pharmacodynamics, 2012, v. 39, n. 3, p. 239, doi. 10.1007/s10928-012-9245-5
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- Publication type:
- Article
Application of the Optimal Design Approach to Improve a Pretransplant Drug Dose Finding Design for Ciclosporin.
- Published in:
- Journal of Clinical Pharmacology, 2012, v. 52, n. 3, p. 347, doi. 10.1177/0091270010397731
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- Publication type:
- Article
Ethically Attractive Dose-Finding Designs for Drugs With a Narrow Therapeutic Index.
- Published in:
- Journal of Clinical Pharmacology, 2012, v. 52, n. 1, p. 29, doi. 10.1177/0091270010390041
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- Publication type:
- Article
Optimal Design in Population Kinetic Experiments by Set-Valued Methods.
- Published in:
- AAPS Journal, 2011, v. 13, n. 4, p. 495, doi. 10.1208/s12248-011-9291-8
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- Publication type:
- Article
Multinomial Logistic Functions in Markov Chain Models of Sleep Architecture: Internal and External Validation and Covariate Analysis.
- Published in:
- AAPS Journal, 2011, v. 13, n. 3, p. 445, doi. 10.1208/s12248-011-9287-4
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- Publication type:
- Article
A Fast Method for Testing Covariates in Population PK/PD Models.
- Published in:
- AAPS Journal, 2011, v. 13, n. 3, p. 464, doi. 10.1208/s12248-011-9289-2
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- Publication type:
- Article