This is a 3-day course designed to present advanced concepts on pharmacometrics using novel methodologies based on integrated drug-disease-trial models, surface response analysis and clinical trial simulation.

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Course outline

 

Advanced PK modeling

• Characterize the complex in-vivo absorption processes of extended release formulations (ER) and Long Acting Injectable (LAI) formulations using convolution-based approach

• Evaluate In-Vitro/In-Vivo correlation methods, including convolution-deconvolution approach

 

Advanced exposure-response modeling

• Evaluate the relationship between drug exposure and clinical response

• Develop models accounting for the confounding role of time varying placebo response in the assessment of the clinical response

• Handling acute tolerance effect

• Estimate the probability of clinical benefit of a treatment

 

Optimizing drug performances

• Implement drug optimization strategies using surface-response analysis

• Determine the relationship between drug delivery and clinical benefit

• Determine dose, dosage regimen and dosing strategies for optimizing the clinical benefit

 

 Course objectives

• To develop a population PK model for describing multiphase absorption profiles

• To implement IVIVC using convolution-based modeling approach

• To implement exposure-response models accounting for time varying placebo response and drug relate response

• To evaluate the relative impact of the immediate and the delayed drug release on the therapeutic response

• To determine the optimal drug formulation profiles for optimizing the performances of novel drug formulations

• To evaluate optimal drug performances (i.e. dose, dosage regimen, in-vivo release properties) using surface response analysis and non-linear optimizer tools

 

Course material

The R scripts (including Shiny based applications) used in the hands-on sessions and the NONMEM control streams will be distributed to the participants. The material includes:

• the convolution/deconvolution analysis,

• the clinical trial simulator for describing the clinical response in presence of placebo and active drug response,

• the estimation of the optimal in-vitro dissolution profiles

• the convolution/deconvolution analysis,

• the non-linear optimizer used in the surface-response analysis