Скачать или смотреть Webinar - Managing Challenging Bioanalysis for PK/PD assessments for Phase I Biologic

Ensuring collaboration between bioanalytical experts and clinical trial sites for Phase I biologics studies is critical for successful drug development. This webinar will outline key clinical and bioanalytical considerations to enable appropriate pharmacokinetics/pharmacodynamics (PK/PD) data for biologics.

This webinar will highlight practical considerations for the successful conduct of first-in-human Phase I studies for biologics where substantial and challenging bioanalysis is required. A Phase I trial is the first opportunity for drug developers to translate observations from preclinical testing into humans. Such trials for biologics have become more complex, with multiple objectives, such as safety, tolerability, PK/PD, and food effects. Additional considerations include participant age, gender, ethnicity, interactions with co-administered therapies, and therapeutic outcome in a small population suffering from illness. Incorporating appropriate bioanalysis for timely PK/PD interpretations, and the need to manage costs, are additional challenges that must be overcome for successful program completion.

The clinical site relies on the bioanalytical experts to generate critical data needed for the understanding of PK/PD parameters. Appropriate bioanalytical strategies and platforms are needed to measure the parent drug and relevant metabolites, and to evaluate potential immunogenicity and biomarkers. Because of the diverse nature of biologics, no single bioanalytical approach can fulfill all the requirements. Analytical techniques are often used in conjunction, including immunoassays — which are sensitive and have high throughput — and LCMS-based methods, which have exquisite specificity. In this webinar, the following three areas will be discussed to optimize the clinical site and bioanalytical teams’ partnerships:

1. Planning for bioanalytical endpoints in Phase I biologics studies, with special emphasis on design and sample preparation
2. Assay selection, requirements, and regulatory expectations
3. Novel workflows focused on minimizing cost and timelines
Altasciences is an integrated drug development solution company, offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to their preclinical and clinical study needs. From lead candidate selection to proof of concept, we offer one-stop integrated formulation, preclinical and clinical manufacturing and analytical services. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements.

Altasciences… helping sponsors get better drugs to the people who need them, faster. Visit our website to learn more: https://www.altasciences.com/