ISSUE NO. 29 — Building Your Early Phase Clinical Data, from Protocol to Regulatory Submission
Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.
In this journal, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.
In Issue 29 of The Altascientist we explore:
- Protocol development
- Data management
- Statistical support
- Analysis and reporting
Test Your Bioanalytical Knowledge
Altasciences has been delivering excellence in bioanalytical services for more than 25 years, so it suffices to say we know a thing or two about bioanalytical studies. But how much do you know about bioanalysis?
See how you score on this 5-question sampling of bioanalytical facts!
As a young company new to drug development, we chose to work with Altasciences because of their experience and reputation for excellence. Altasciences has been a great partner for us in the early drug development phase; they helped us navigate the difficult path from formulation through to clinical manufacturing. In one short year, we have gone from idea through to Phase III clinical trials. They operate in a fully qualified, FDA-inspected cGMP facility. Their team meets with us weekly to keep us informed, and is always approachable and available for questions, comments, or concerns.
Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
In Vivo and Histological Analysis of Focal Chorioretinal Defects in Dutch Belted Rabbits
Establishment of an Induced Hemophilia A Model in Anesthetized Cynomolgus Monkeys
A Case Study Comparison of Two Preclinical Studies Utilizing Traditional Versus Modified Methods for Surgical Closing and Post-Operative Treatment for Muscle Biopsy Sites in Nonhuman Primates
Drug Discovery World: Space to Innovate—Where Are Biotech's Top Expansions?
Characterization of Normal Skin Thickness For Various Body Regions, Ages, and Genders of Yucatan Miniature Swine
Miniature Swine Model of Atopic Dermatitis—Assessment of In Vivo and In Vitro Activity of Recombinant Porcine Interleukin-4 and Interleukin-13