Pharmacokinetics and Pharmacodynamics in Drug Registration

  • ID: 2863578
  • Training
  • Leopink
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Pharmacokinetic and pharmacodynamic (PK/PD) studies play a vital role in drug development. Regulatory authorities are placing greater emphasis on the role of PK/PD in drug registration. This module enables the learner to understand the role of PK/PD data in establishing the safety profile of a new or generic product.


- Explain the role of PK/PD studies in modern drug development and registration.

- Describe the use of PK/PD data from preclinical and clinical studies.

- Recognise the role of PK parameters in special population studies.

- Identify the processes used to obtain PK/PD data from nonclinical and clinical trials.

- Describe the PK/PD factors underpinning the concepts of bioavailability and bioequivalence.
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PK/PD role and relevance
The role and relevance of PK and PD in the registration of new and generic drugs is described. The emerging trend towards formal standardisation of PK studies is discussed.

PK/PD studies in drug development
The role of PK/PD studies in nonclinical and clinical studies is explained. Study designs are discussed. Bioavailability, ADME and toxicokinetic studies are described. A variety of clinical studies are outlined in the context of PK.

Drug administration routes
Time-concentration curves for various routes of administration are compared. Prediction of the best route, on the basis of PK data, is discussed.

PD for drug registration
The distinction between PD effects and clinical outcomes is explained. Examples of dose-response curves and their interpretations are given. The importance of dose-response relationships in clinical trials and drug registration is discussed.

Sampling practice and outcomes
Common PK variables derived from sampling are described. Good sampling practice is discussed.

Data analysis
Compartmental and non-compartmental analysis are compared. Uses of AUC and volume of distribution are described.

Special populations
Requirements for studies in populations such as those with liver or kidney dysfunction are described.

Generics and bioequivalence
The principles and practice of bioequivalence studies for the registration of generic products are described.

Multiple-choice mastery assessment.
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