BioPharma Dive: The Golden Era of GLP-1 Drugs: Where We Are and What Comes Next
ISSUE NO. 40 — Analytical Testing: Accurate and Complete Characterization of Your API to Maximize Bioavailability
In Issue 40 of The Altascientist, different analytical testing techniques to support drug product development specific to bioavailability are explored, including a case study on the manufacturing of a nanosuspension.
During the early stages of drug development, fully characterizing the active pharmaceutical ingredients (APIs) is crucial for optimizing the drug product formulation. Specifically, understanding your API’s particle size, crystalline structure (including different polymorph forms), and dissolution profile to inform downstream formulation dosing decisions for clinical trials.
In this issue of The Altascientist, you will discover:
- methods for identifying and characterizing your API;
- common techniques to determine particle size distribution (PSD);
- formulation approaches to maximize bioavailability; and
- a nanosuspension case study.
Case Study: Innovative Nanosuspension Approach to Maximize API Potency in Preclinical Formulation Development
Each preclinical&nbs
T-cell-dependent Antibody Responses and Immunopathology: A Comparative Study in Juvenile Cynomolgus Monkeys
Incidence of Neutralizing Adeno-Associated Viral Antibody Subtypes in Cynomolgus Monkeys of Cambodian, Mauritius, and Philippines Origins
Germline Integration Assessment in Preclinical Gene Therapy Studies
Key Considerations for Nonclinical AAV Gene Therapy Development
Case Study: How to Evaluate Human Abuse Potential (HAP) for CNS Drugs
Case Study—Nanosuspension Formulation to Maximize Potency for Preclinical Studies