Qualification of a Veterinary Glucometer for Use in Yucatan Miniature Swine
Liquid-Filled Capsules: An Attractive, Marketable Solution
A Scalable Solution for Solubility Challenges
Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs
Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing. This blog explores the process required for manufacturing a highly potent API for an ophthalmic indication, based on a case study involving loteprednol etabonate, a topical corticosteroid used to treat eye inflammations.
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.