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1. 1. Garnishing the smorgasbord of pharmacometric methods

   Författare :Henrik Bjugård Nyberg; Andrew Hooker; Johannes Schropp; Uppsala universitet; []
   Nyckelord :MEDICIN OCH HÄLSOVETENSKAP; MEDICAL AND HEALTH SCIENCES; pharmacometrics; pharmacokinetics; saddle points; nonidentifiability; modelling and simulation; tuberculosis; ethionamide; bioequivalence; model-integrated evidence; Farmaceutisk vetenskap; Pharmaceutical Science;

   Sammanfattning : The smorgasbord of methods that we use within the field of pharmacometrics has developed steadily over several decades and is now a well-laid-out buffet. This thesis adds some garnish to the table in the form of small improvements to the handling of certain problems. LÄS MER

3. 2. Methods for handling model misspecification in pharmacometric model-based approaches for the analysis of longitudinal clinical trial data

   Författare :Estelle Chasseloup; Mats Karlsson; Andrew Hooker; Karl Brendel; Uppsala universitet; []
   Nyckelord :MEDICIN OCH HÄLSOVETENSKAP; MEDICAL AND HEALTH SCIENCES; pharmacometrics; nonlinear mixed-effects models; misspecification; type I error; power; accuracy; placebo; individual model averaging; IMA; likelihood ratio test; LRT; model averaging; covariate selection; mixture models; visual predictive checks; VPC; avatars; digital twins; virtual individual; Farmaceutisk vetenskap; Pharmaceutical Science;

   Sammanfattning : Pharmacometrics model-based analyses proved to be increasingly useful in drug discovery and development. This usefulness was made evident by the formalisation of the model-integrated drug discovery and development framework (MID3). LÄS MER

4. 3. Benefits of Non-Linear Mixed Effect Modeling and Optimal Design : Pre-Clinical and Clinical Study Applications

   Författare :Charles Ernest II; Andrew Hooker; Mats Karlsson; Bart Ploeger; Uppsala universitet; []
   Nyckelord :MEDICIN OCH HÄLSOVETENSKAP; MEDICAL AND HEALTH SCIENCES; Pharmacometrics; optimal design; nonlinear mixed effects models; population models; Pharmaceutical Science; Farmaceutisk vetenskap;

   Sammanfattning : Despite the growing promise of pharmaceutical research, inferior experimentation or interpretation of data can inhibit breakthrough molecules from finding their way out of research institutions and reaching patients. This thesis provides evidence that better characterization of pre-clinical and clinical data can be accomplished using non-linear mixed effect modeling (NLMEM) and more effective experiments can be conducted using optimal design (OD). LÄS MER

5. 4. Methodology for Handling Missing Data in Nonlinear Mixed Effects Modelling

   Författare :Åsa M. Johansson; Mats O. Karlsson; Andrew C. Hooker; Leon Aarons; Uppsala universitet; []
   Nyckelord :MEDICIN OCH HÄLSOVETENSKAP; MEDICAL AND HEALTH SCIENCES; Pharmacometrics; population models; censored observations; missing covariates; missing dependent variable; missing data mechanism; missing completely at random MCAR ; missing at random MAR ; missing not at random MNAR ; estimation algorithms; Pharmaceutical Science; Farmaceutisk vetenskap;

   Sammanfattning : To obtain a better understanding of the pharmacokinetic and/or pharmacodynamic characteristics of an investigated treatment, clinical data is often analysed with nonlinear mixed effects modelling. The developed models can be used to design future clinical trials or to guide individualised drug treatment. LÄS MER

7. 5. Nonlinear Mixed Effects Methods for Improved Estimation of Receptor Occupancy in PET Studies

   Författare :Matts Kågedal; Mats Karlsson; Andrew C Hooker; Gitte Knudsen; Uppsala universitet; []
   Nyckelord :NATURVETENSKAP; NATURAL SCIENCES; PET; positron emission tomography; receptor occupancy; nonlinear mixed effects; NONMEM; optimal design; dose finding; Pharmacokinetics and Drug Therapy; Farmakokinetik och läkemedelsterapi;

   Sammanfattning : Receptor occupancy assessed by Positron Emission Tomography (PET) can provide important translational information to help bridge information from one drug to another or from animal to man. The aim of this thesis was to develop nonlinear mixed effects methods for estimation of the relationship between drug exposure and receptor occupancy for the two mGluR5 antagonists AZD9272 and AZD2066 and for the 5HT1B receptor antagonist AZD3783. LÄS MER