ISSUE NO. 42 — Managing The Complexities of Glucagon-Like Peptide-1 Receptor Agonist Drug Development
Current and future development of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or simply GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.
In Issue 42 of The Altascientist, we review the requirements for successful GLP-1 drug development, including:
- preclinical approaches
- early-phase clinical study design
- bioanalytical techniques
- manufacturing
Two case studies are also included.
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