ISSUE NO. 33 — End-to-End CNS Drug Development Solutions
In Issue 33 of The Altascientist, we explore how a comprehensive, end-to-end integrated approach to drug development for central nervous system (CNS) therapeutics can take you seamlessly from lead candidate selection to market.
Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.
With detailed case studies, study considerations, and more, this Issue covers:
- preclinical safety and toxicity testing,
- formulation and manufacturing,
- early-phase clinical trials, and
- bioanalysis.
Four Key Steps to Optimizing a Large Molecule Bioanalytical Program
Biologics are large, complex molecules that can undergo structural changes during the manufacturing process, storage, or administration to patients. This means bioanalysis of biologics is a critical aspect of the drug development process, and one that requires sensitivity, specificity, and selectivity.
Get Ahead of the Game with Flexible Phase 1 Study Timing
Development of a Flow Cytometry Phospho-STAT5 Assay in Nonhuman Primate T Cells
Strategies for Reducing the Number of Animals in Toxicity Testing: A Comparative Approach for Rodent and Large Animal Studies
Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors: Historical Data Review to Characterize Common Challenges and Identify Opportunities for Refinement
Comparison of Toxicology Assessment Baseline Data Collected Using Two Restraint Methods in Nonhuman Primates: Restraint Chair/Pole and Collar vs. Procedure Cage
Downsized Sinclair™ vs. Göttingen™ Minipigs Similarities and Differences of Toxicological Reference Range Data in Preclinical Safety Studies
Ocular Imaging and Microscopic Analysis of Focal Chorioretinal Defects in Rabbits
Validation of an SC5b-9 Commercial Kit for Preclinical Biomarker Analysis