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…
Month: January 2022
Knowledge Management and Knowledge Mapping (1 of 2)
Stuart R. Gallant, MD, PhD Any successful drug development program generates a massive amount of information. Just the NDA can run to more than 100,000…
Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)
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,…
Risk Assessment of Raw Materials and Contact Materials (1 of 2)
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…
The Value of Medications (2 of 2)
Stuart R. Gallant, MD, PhD This is the second post in a two-part series on the value of medications. In this post, we bite the…
The Value of Medications (1 of 2)
Stuart R. Gallant, MD, PhD This post is the first in a two-part series on the value medications. “The Value of Medications” is a bit…
Lessons Learned: Documenting Your Intellectual Property and Defending It
Stuart R. Gallant, MD, PhD Some readers may not have had the opportunity to be deposed by the opposing counsel from a pharmaceutical company. Here…