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Course Description:

Basic concepts in development and validation of assays for pharmacokinetic analysis continue to be a constant presence in an evolving pharmaceutical industry. Even with the advent of new modalities, such as bi-specific antibody drugs and oligonucleotide drugs, the process to develop and validate PK assays is like that for large molecule simple antibody therapeutic agents. This online seminar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK assays for biologics. Specifically addressed are regulatory agency expectations with key analysis of assay variability, considerations for disease specific matrices, and using checkerboard approaches in early development. The format of the online seminar offers an examination of current best practices to guide attendees toward a better approach to achieving rugged validated assays.

Key Learning Objectives:

1. Understanding expectations for validated PK assays (timelines)
2. Differences between preclinical and clinical methods
3. Overview of regulatory agency guidance documents
4. Designing PK assays for validation success
5. Validating per regulatory guidance documents

Topics covered include:

1. Assay expectations in regulated labs for each phase of drug development GCLP (GCP, GLP)
2. Impact of matrix
3. MRD and sensitivity
4. Addressing plate effects
5. Checkerboard approach
6. Determining the quantitative limits of the assay
7. Building in robustness/ruggedness
8. Documentation – following the protocol
9. Validating methods per FDA/EMA guidance documents

This training video will provide valuable information to:

1. Quality Assurance Specialists and Managers
2. Development and Validation Scientists
3. Regulatory Affairs
4. Consultants
5. Quality Assurance Personnel

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