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November 23, 2022

Oral Delivery of Protein Drugs

Clinical, CMC, Medical, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Pre-Clinical, Uncategorized

Stuart R. Gallant, MD, PhD Proteins and peptides are commonly delivered subcutaneously and by infusion; however, these approaches have disadvantages.  Among the chief problems are:…

Stuart Gallant
November 14, 2022

Immediate, Delayed, and Extended-Release Drug Products

Analytical, Clinical, CMC, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Uncategorized

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…

Stuart Gallant
August 6, 2022

Pharmaceutical Decision Making and Fundraising

Clinical, Finance, Pharma Economics, Pharmaceutical Development, Planning, Portfolio Management, Pre-Clinical, Risk Management, Uncategorized

Stuart R. Gallant, MD, PhD Within pharmaceutical development, there are two types of go-no-go decisions:  1) clinical and 2) financial.  These decisions are linked together…

Stuart Gallant
March 14, 2022

Technology Focus:  Supercritical Fluid Chromatography

Analytical, Pharmaceutical Manufacturing, Uncategorized

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…

Stuart Gallant
January 17, 2022

Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)

CMC, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Raw Materials, Uncategorized

Stuart R. Gallant, MD, PhD In the first post of this series, raw materials risk analysis was discussed.  In the second post of this series,…

Stuart Gallant

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