An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration

Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.

Module overview - An outline of the module’s scope and objectives, and notes on terminology.

Role of pharmacokinetics and pharmacodynamics - Although pharmacokinetic (PK) and pharmacodynamic (PD) studies are routinely carried out in nonclinical and clinical stages ofdrug development, their role is perhaps less well understood than it ought to be by those who are not specialists in the field. In addition, greater emphasis is being placed by regulators on the value of PK and PD data. Evidence of good practice in the execution of PK and PD studies, and sound understanding of the implications of their findings, are becoming increasingly important in drug registration.

In this session we define PK and PD, outline the uses of PK and PD data in a drug development programme, and give examples of how good practice in obtaining and interpreting PK and PD data can contribute to the minimisationof risk for a drug.

PK and PD studies in drug development - In this session we discuss the various types of study carried out to acquire pharmacokinetic and pharmacodynamic data, grouping them into those conducted in animals only, in animals and humans, and in humans only. We identify their goals, rationale, and place in a drugdevelopment programme.

Drug administration routes - In this session, after introducing the principal pharmacokinetic parameters, we describe the PK and PK/PD characteristics of each drug administration route. We discuss the different medical-scientific questions to be addressed by PK/PD research for the different routes

Pharmacodynamic studies - In this session we discuss the scope of pharmacodynamics, distinguish pharmacodynamic from clinical outcomes, and outline how the former may be used as surrogates for the latter. The core information from PD studies is a quantitative description of the dose–response relationshipand the influence of various factors on this relationship. We emphasise the importance of interpreting the shape of the dose–response curve in making major decisions on a drug’s development. Finally, we discuss factors that can influence the beneficial and adverse effects of a drug.

Pharmacologists, nonclinical researchers, clinical researchers, regulatory affairs staff, and others who contribute to drug development and registration will benefit from this module.

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• Safari
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• A high-speed internet connection will provide best results.
• An email address is required to register for courses.
• Microsoft Media Player or equivalent is needed to play audio and video files.
• Flash Player is used for content and interactive learning. If necessary, download and install Flash Player to ensure proper operation of course content.

1. What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.

2. Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).

3. Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

4. Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

5. What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.

System requirements

• Chrome
• Safari
• Internet Explorer
• Firefox

• A high-speed internet connection will provide best results.
• An email address is required to register for courses.
• Microsoft Media Player or equivalent is needed to play audio and video files.
• Flash Player is used for content and interactive learning. If necessary, download and install Flash Player to ensure proper operation of course content.

1. What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.

2. Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).

3. Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

4. Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

5. What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.