Drug Development Process: Nonclinical Development of Small-Molecule Drugs-Reference-Cited by-同舟云学术

Drug Development Process: Nonclinical Development of Small-Molecule Drugs

Published:2022-10-01 Issue: Volume: Page:484-492
ISSN:1939-1889
Container-title:LCGC North America
language:en
Short-container-title:LCGC N. Am.

Author:

Dong Michael W.¹

Affiliation:

1. MWD Consulting

Abstract

This article provides a high-level overview of the drug development process of small-molecule drugs for the analytical chemist. Emphasis is given to the nonclinical development and roles of the technical development organization in driving the new drug development project from toxicology studies to new product registration. A case study of the career path of a separation scientist is used to illustrate the diversified roles of an analytical chemist in drug development.

Publisher

Multimedia Pharma Sciences, LLC

Subject

Analytical Chemistry

Reference14 articles.

1. M.W. Dong, LCGC North Am. 40(6), 252–257 (2022).

2. M.W. Dong, LCGC North Am. 40(8), 344–350 (2022).

3. R.G. Hill and H.P. Rang, Eds., Drug Discovery and Development: Technology in Transition (Churchill Livingston, Edinburgh, United Kingdom, 2nd ed., 2012), Chapters 4–11.

4. B.E. Blass, Basic Principles of Drug Discovery and Development (Academic Press, New York, NY, 1st ed., 2015).

5. M.W. Dong, “Drug Discovery and Development Processes,“ Pittcon 2019 short course presented at Pittcon, Philadelphia, PA, 2019.

Cited by 3 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Certificate of Analysis (CoA) and Calculations for Small-Molecule Drugs;LCGC International;2024-06-01

2. Current Good Manufacturing Practice (cGMP): An Overview for the Analytical Chemist;LCGC North America;2023-11-01

3. Good Laboratory Practice (GLP): An Overview for the Analytical Chemist;LCGC North America;2023-10-01