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From low- to high-throughput analysis
Ann Lévesque1, Sofi Gagnon-Carignan1, Sylvain Lachance1
1inVentiv Health Clinical, Québec, Canada.
Bioanalysis
|December 15, 2015
Summary
Transitioning from low- to high-throughput analysis for pharmacokinetic (PK) studies presents significant challenges due to stringent regulatory guidelines. Contract research organizations must adapt to meet these demands for efficient drug development.
Area of Science:
- Pharmacokinetics and Drug Development
- Analytical Chemistry
- Regulatory Science
Background:
- High-throughput analysis is standard in early drug discovery (screening, toxicity).
- Regulated pharmacokinetic (PK) analysis demands higher standards than early discovery.
- Applicable to diverse drug types, from small molecules to biologics.
Purpose of the Study:
- To outline the challenges in transitioning laboratory analysis from low- to high-throughput.
- To address the specific demands of high-throughput PK analysis in regulated studies.
- To prepare contract research organizations (CROs) for faster turnaround times.
Main Methods:
- Description of laboratory challenges in scaling up analytical processes.
- Focus on meeting regulatory guidelines for high-throughput PK analysis.
- Strategies for achieving rapid results in complex analytical workflows.
Main Results:
- Identification of key obstacles in implementing high-throughput PK analysis.
- Demonstration of the need for robust analytical methods.
- Highlighting the importance of efficient data management and reporting.
Conclusions:
- Transitioning to high-throughput PK analysis requires overcoming significant technical and regulatory hurdles.
- CROs must invest in advanced technologies and streamlined processes.
- Successful implementation is crucial for meeting the fast-paced demands of modern drug development.
