Master in Biopharmaceutical Sciences

Biopharmaceutics and Pharmacokinetics

ECTS

4

Learning outcomes

The primary objective of this CU is to provide a conceptual and quantitative background in pharmacokinetic theory and applications needed to pursue advanced studies in Clinical Pharmacokinetics and Biopharmaceutics as applied to drug administration and delivery systems.

The specific learning objectives for the pharmacokinetics section of this CU include the following:

  1. Students will be able to estimate pharmacokinetic parameters using plasma drug level data.
  2. Students will be able to predict the effects of various physicochemical, biochemical, physiological and pathological processes on the kinetics and extent of drug absorption, distribution and elimination (ADME).
  3. Students will be able to use empirical pharmacokinetic models to devise and optimize dosage regimens.
  4. Students will be able to relate the effects of dosage form design and routes of drug administration on therapeutic drug levels optimization.

 

Syllabus

Description and quantitation of factors affecting the absorption, distribution, metabolism and excretion (ADME) of drugs. Development of appropriate dosage regimens and graphical analysis of drug concentration data sets. Bioequivalence and drug product testing. Application of biopharmaceutical and pharmacokinetic theory to clinical problems involved in optimizing and monitoring drug use in patients.

The syllabus represents an organized plan with increasing levels of complexity aiming the integration of theoretical concepts with professional practice. Lectures cover the subject materials in a classical one-way interaction mode. Practical work includes use of manual/hand calculator methods and software applications (PKS) to solve practical cases, aiming at the estimation of individual PK parameters and establishment/modification of dosing regimens. This approach allows solving practical cases with increasing complexity.

The syllabus represents an organized plan with increasing levels of complexity aiming the integration of theoretical concepts with professional practice. Lectures cover the subject materials in a classical one-way interaction mode. Practical work includes use of manual/hand calculator methods and software applications (PKS) to solve practical cases, aiming at the estimation of individual PK parameters and establishment/modification of dosing regimens. This approach allows solving practical cases with increasing complexity.

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