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Pharmacokinetic and pharmacodynamic (PK & PD) analysis in drug developmentBasic course
The goal of the course is to expose participants to the mechanisms that determine the processes of transport and activity of biological drugs in the body, the approaches to analyzing and understanding these mechanisms using pharmacokinetic and pharmacodynamic models, and their application for the purpose of informed preclinical and clinical development of biological drugs. The course presents scientific principles alongside...Continue reading
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Issues to be covered
- Families of biologics (antibodies, antibody-drug conjugates, proteins, peptides, nucleic acids, etc.
- Analytical methods for quantification of biologics in biological samples
- Mechanisms of absorption, distribution, and clearance of biologics
- Structure-dose-concentration-activity relationships of biologics
- Including the relationship between the structure of biologics, half-life, desired activity, and immunogenicity
- Target-Mediated Drug Disposition (TMDD) of Biologics
- Approaches to the analysis of biologic drug concentration and activity data:
- Non-compartmental pharmacokinetic analysis
- Compartmental pharmacokinetic analysis
- Pharmacokinetic-pharmacodynamic (PK/PD) models
- Pharmacokinetic-pharmacodynamic models and their application in the preclinical and clinical development of biological drugs:
- Model selection
- Model characterization and evaluation
- Prediction of pharmacokinetics and pharmacological activity in animals and humans
- Case studies of specific biological drugs: analysis using dedicated computer software (free software that participants can continue to use after completing the course)
- Demonstration of commercial computer software that allows for the analysis of pharmacokinetic and pharmacodynamic data of biological drugs
- Initial analysis of participants’ experimental data (optional)
Who should attend
- Professionals (researchers, managers, staff, etc.) involved in preclinical and/or clinical research of biological drugs
- Quality and regulatory managers and administrative personnel who are exposed to the results of preclinical and/or clinical trials of biological drugs
- Statisticians interested in acquiring knowledge in the field of pharmacokinetic and pharmacodynamic data analysis of biological drugs
- Students who are interested in the field
Benefits to the Participants
- Understanding the processes that biological drugs undergo in the body
- Introduction to desired pharmacological activities and side effects of biological drugs
- Understanding the relationship between the structure of biological drugs, the exposure to them, and the balance of their pharmacological activities
- Introduction to approaches for the intelligent design of biological drugs
- Introduction to mathematical models used to investigate the processes of transport and activity of biological drugs
- Presentation of the uses of these tools in the preclinical and clinical development of biological drugs
About The Lecturer
