Clinical Trials
First-in-Human-Enabling Toxicology Programs: Common Misconceptions by Grace M. Furman
Nomination of a clinical candidate and subsequent conduct of toxicology studies to support a first-in-human (FIH) clinical trial is an exciting milestone for sponsors! While many are highly experienced drug discovery professionals, some may have limited, or even no experience, in early clinical development, including the critical toxicology studies required to successfully support a FIH trial.
How Clinic-Ready Manufacturing and Adaptive Clinical Trials Can Reduce Drug Development Timelines
The complexities of active pharmaceutical ingredient (API) formulation, product testing, and documentation requirements can hinder the speed at which a promising drug candidate progresses to and through clinical trials.
The Year in Review 2025
Case Study: Applying Scientific Expertise to Optimize Complex Safety-Focused DDI Studies
Drug-drug interactions (DDIs) can pose significant safety risks, particularly in cardiovascular therapies, where patients are often on multiple medications. By analyzing these interactions early, we can help your studies stay on track and avoid potential regulatory roadblocks.
Case Study—Accelerating Recruitment in Renal Impairment Trials: Leveraging Specialized External Sites
STAT: Responsible AI Frees Scientists to Focus on Science
CLINDMO: Where Clinical Innovation Meets Manufacturing Excellence
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
Clinical Trials Without Boundaries: Multi-Site Solutions at Altasciences