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CATALENT XPRESS PHARMACEUTICS® |
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Integrated Development Offering to Facilitate Adaptive Trials and Accelerate Phase 1 |
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A more advanced development offering that integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human (FIH) studies and expedite development.
Key Benefits: |
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Quick to First-in-Human and proof of concept studies using on-demand manufacturing close to the point of administration Flexible formulation strategies for rapid dose adjustment at the phase 1 CRO Significant savings on both API and time Allows better decision making using real time clinical data Supports customers’ regulatory filing strategies
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Upcoming Webinar: Enabling Adaptive Clinical Trials through Integrated Development and Manufacturing Solutions |
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Date: May 21, 2024 Time: 11am – 12pm EDT |
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The adoption of adaptive designs in clinical trials represents a paradigm shift towards a more efficient and flexible approach, overcoming the limitations of traditional fixed designs. Join this webinar as industry experts deep dive into the secrets of successful drug development and how adaptive trials can help get your molecule through Phase 1 faster. |
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Case Study: Enhancing Drug Performance Through Lipid-Based Formulations for CNS Indication |
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A clinical-stage biopharmaceutical company developed a potent and highly selective inhibitor of Bruton Tyrosine Kinase (BTK) to treat hematologic malignancies with central nervous system (CNS) involvement. Learn how Catalent experts were able to address patient-to-patient variation, bioavailability, and inherent API chemical instability concerns of this first-in-class molecule to get a more predictable and reliable drug response. |
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Article: Targeted Protein Degraders: Through the Lens of the Innovation, Developability, and CMC Challenges |
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Developing bifunctional TPDs with good oral bioavailability can be challenging, and a number of issues can arise throughout development. Download this article to learn how to inform the selection and development of orally bioavailable drugs, as well as CMC approaches to efficiently develop and manufacture targeted protein degraders. |
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| View Article | | | | Every program has a challenge. We have a solution.
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