Phase 1
Phase 2
Phase 3
Preclinical
Quality by Design Approach to Analytical Method Optimization
Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products.
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Phase 1
Preclinical
Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening
Read this case study to learn how a team of bioavailability experts at Catalent took a target molecule from early stage to Phase 1 in under nine months.
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Commercial
Phase 1
Phase 2
Phase 3
OneXpress Case Study – Enabling Successful SDD Scale Up
Read this case study to learn about how Catalent deployed its integrated OneXpress® Solution to expedite the transfer of a partner program to one of its late-stage manufacturing sites while optimizing the utilization of a limited supply of API.
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Phase 1
Phase 2
Preclinical
Why Formulation Technologies are Critical to the Success of the Next Generation of Small Molecule Oral Drugs
By taking advantage of modern screening technologies to collect and leverage molecular data early on, drug developers can bridge the gap between molecule discovery and dose form selection.
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Phase 1
Phase 2
Phase 3
Preclinical
From Molecule to Dose Form – Accelerated Bioavailability Enhancement for Early Phase Molecules
This eBook is a selection of articles published in the Journal of Drug Delivery Science and Technology, giving overviews on different types of strategies that are used to increase the dissolution rates of poorly water-soluble drugs in order to increase their bioavailability.
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Phase 1
Phase 2
Phase 3
Preclinical
Developing Optimal Formulations Using Biorelevant Predictive Tools and Advanced Bioavailability Enhancement Technologies
API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success when moving from preclinical development to early phase clinical trials.
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Phase 1
Phase 2
Phase 3
Expecting the Unexpected-Strategies for Efficient Clinical Supply Management and Forecasting
This eBook will explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines and to identify potential supply-related issues before they negatively impact your study.
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Commercial
Overcoming Manufacturing Challenges for Accelerated Drug Development
Learn how to leverage the drug development knowledge and build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process.
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Commercial
Phase 1
Phase 2
Phase 3
Preclinical
A Roadmap for Early Development to Commercial Manufacturing
Understanding and planning for phase-appropriate CMC-related activities can facilitate the transition from early development through commercialization.
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Commercial
Phase 1
Phase 2
Phase 3
Preclinical
Concept to Dosing-Challenges in New Orphan Drugs
Summary: In this webinar a group of experienced cancer drug developers discusses key strategies in managing an orphan drug program.
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