| |
| |
Integrated Development Offering to Facilitate
Adaptive Trials and Accelerate Phase 1 |
|
|
Phase 1 clinical studies are sometimes impeded by the reliance on two or more fixed dose strengths, and an inability for the clinic to dynamically adjust dosing based on clinical feedback. Significant opportunity exists therefore to optimize the traditional vertical development approach by increasing flexibility in dose selection. |
|
|
Introducing New Catalent Xpress Pharmaceutics™, 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.
The key benefits of this offering include: |
|
|
| Quick to First-in-Human and proof of concept studies Scalable formulations for rapid dose adjustments at the clinical site Significant savings on active pharmaceutical ingredient, cost, and time Allows better decision making using real-time clinical data Supports customers’ regulatory filing strategies. |
|
|
| |
| |
Upcoming Webinar: Navigating your Biopharma Drug Candidate through Early and Mid-Stage Clinical Trials |
|
|
Date: Tuesday, February 8, 2022
Time: 11 a.m. EST | Decisions made throughout early- and mid-stage clinical trials impact late-stage results and sometimes, entire programs and company performance. Since some obstacles can prove overwhelming for startups, much can be learned from those who have successfully walked the path. Join this webinar to hear a panel of biopharma professionals review approaches to successfully translate benchtop discoveries into clinical trials and CMC strategies to help drug products reach patients faster. |
|
|
| |
Article: Developing Optimized Preclinical
Formulations with Minimal API |
|
|
Summary: During the early phases of oral drug development, it is commonplace to have a limited supply of a given API since oftentimes its synthetic route is not yet optimized for large scale production. A major challenge stemming from a limited API supply is gathering sufficient meaningful data to select the most promising candidates to move forward into in vivo studies and to be able to select a clinical candidate. Download this article to discover various API sparing development techniques that can help create optimized formulations. |
|
|
| |
Executive Summary: A Roadmap for Early Development to Commercial Manufacturing |
|
|
Summary: Download this article to explore how in-depth understanding and planning of phase-appropriate CMC-related activities can facilitate transition from early development through to commercialization. |
|
|
| |
| |
