Case Study: Achieving a 505(B)(2) Regulatory Approval for Multiple NDA-Enabling Studies
Hybrid medicines are drugs based on an approved active substance (or previously approved drug) and have a different route of administration, format, strength, or indication from the original reference product.
They require approval for market authorization based on both data from the original reference medicine, and from new clinical trials on the modified version.
Case Study—Accelerating Recruitment in Renal Impairment Trials: Leveraging Specialized External Sites
7 Tips for Navigating the Complexities of In Vitro NAMs Studies
As a board-certified toxicologist and experienced Good Laboratory Practices (GLP) Consultant, I spend quite a bit of time advising on quality issues of New Approach Methodologies (NAMs) in support of toxicology programs. While these alternative methods are exciting and full of promise, they come with their own set of challenges.
STAT: Responsible AI Frees Scientists to Focus on Science
The CEO Views: Altasciences—Streamlining Drug Development Decision-Making
CLINDMO: Where Clinical Innovation Meets Manufacturing Excellence
Insights Care: Marie-Hélène Raigneau—Powering a New Era of Early-Phase Drug Development
Time Iconic: Chris Perkin—Transforming Drug Development With Purpose-Driven Leadership and an Industry-Changing Vision
ISSUE NO. 46 – Spray-Dried Dispersions
Spray-dried dispersions (SDDs) are an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. The spray drying process involves converting a liquid into a dry powder, with the resulting SDDs benefiting from improved characteristics for further developments. Spray drying can also be combined with nanomilling to further improve the bioavailability, and for flexible downstream processing.
In Issue 46 of The Altascientist, explore:
- how SDDs improve efficiency of early-phase drug development
- applications and benefits of spray drying in early-phase drug manufacturing
- advances in spray drying technology for pharmaceutical development
- the use of spray dry technology in early-phase development of proteins and peptides
- key considerations for the development of spray-dried pharmaceuticals