Stuart R. Gallant, MD, PhD Pharmaceutical shelf-life determination affects patient safety by assuring that the strength, quality, purity, and potency of an investigational or commercial…
Analytical
Selecting an Analytical Laboratory
Stuart R. Gallant, MD, PhD Analytical testing is required to verify the identity, strength, quality, purity, and potency of investigational and commercial products. The precise…
Small Molecule and Antibody Release Specifications—Lessons Learned
Stuart R. Gallant, MD, PhD Drug substance and drug product release specifications have numerous uses throughout the product lifecycle. They guide process development and provide…
Plant-Based Drug Discovery—Nature’s Pharmacy
Stuart R. Gallant, MD, PhD Before there was a pharmaceutical industry, humans looked to plants as source of medicines. Today’s post focuses on medicines derived…
Immediate, Delayed, and Extended-Release Drug Products
Stuart R. Gallant, MD, PhD The focus of today’s post is oral drug release—immediate, delayed, and extended. Many technologies exist for controlling drug release—the focus…
Technology Focus: Supercritical Fluid Chromatography
Stuart R. Gallant, MD, PhD This post is the first in an occasional PharmaTopoTM series called “Technology Focus.” Today, we look at supercritical fluid chromatography…
Nonclinical and CMC (3 of 3)
Stuart R. Gallant, MD, PhD Non-clinical development has two chief goals: 1) to develop safety data enabling the entry of the medicine into human clinical…