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Tag: Drug Development

January 4, 2024

Plant-Based Drug Discovery—Nature’s Pharmacy

Analytical, Antibiotics, CMC, Patent, Pharmaceutical Development, Pharmacy, Pre-Clinical

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…

Stuart Gallant
July 17, 2022

Treatments for Alzheimer’s Disease (2 of 2)

Clinical, Pharmaceutical Development, Pharmacy

Stuart R. Gallant, MD, PhD Having discussed the pathological processes of Alzheimer’s disease in the first part of this post, the current status of Alzheimer’s…

Stuart Gallant
July 17, 2022

Treatments for Alzheimer’s Disease (1 of 2)

Clinical, Pharmaceutical Development

Stuart R. Gallant, MD, PhD One of the most useful words in medicine is “multifactorial.”  Commonly, in science and medicine, we struggle to find a…

Stuart Gallant
January 21, 2022

Knowledge Management and Knowledge Events (2 of 2)

CMC, Knowledge, Pharmaceutical Manufacturing

Stuart R. Gallant, MD, PhD The first part of this two-post series addressed knowledge management and knowledge mapping.  In this second part, the use of…

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
January 17, 2022

Risk Assessment of Raw Materials and Contact Materials (1 of 2)

CMC, Pharmaceutical Manufacturing, Planning, Raw Materials

Stuart R. Gallant, MD, PhD One of the first steps in a pharmaceutical development project is selection of chemicals.  For the development team, it may…

Stuart Gallant
December 31, 2021

Drug Development Plan

Clinical, CMC, Patent, Planning, Pre-Clinical

Stuart R. Gallant, MD, PhD How A Drug Development Plan Originates Keller and Schnell suggest that there are five challenges to a pharmaceutical startup:  1)…

Stuart Gallant
December 18, 2021

Intellectual Property (2 of 3)

Clinical, Patent, Pharma Economics, Pharmaceutical Manufacturing, Royalty

Stuart R. Gallant, MD, PhD Licensors and Licensees As discussed in Part 1 of this three-part series, drug development and licensing has taken on the…

Stuart Gallant
December 8, 2021

Cost of Pre-Clinical Development (1 of 3)

Clinical, Pharma Economics, Pharmaceutical Manufacturing, Pre-Clinical

Stuart R. Gallant, MD, PhD In the last three decades, how pharmaceutical drug development occurs has changed dramatically.  Prior to this change, a significant share…

Stuart Gallant

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