Phase-appropriate Analytical Methodology

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology Quality and Regulatory Sourcebook March 2023, Volume 2023 eBook , Issue 2
Pages: 4-6

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

Progressing a drug candidate from research to commercialization requires huge sums of money (approximately US$1.5 billion–$4.5 billion) (1) and is inherently high risk due to the high attrition rate. Only approximately
10% of total drug attrition is because of poor strategic planning or a lack of commercial needs (2). Highlighting solid strategy and funding alone is not enough to take a drug to market. Approximately 70–80% of clinical failures can be attributed to a lack of clinical efficacy or toxicity (3),
and the majority of drug failures occurring in pre-clinical and Phase I are due to pharmacokinetics or toxicity issues (4).

Read this article in Pharmaceutical Technology's March 2023 Quality and Regulatory Sourcebook eBook.


About the author

Paul Van Tilborg is director of analytical sciences at Ardena.

Article details

Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2023
Pages: 4-6


When referring to this article, please cite it as Van Tilborg, P. Phase-appropriate Analytical Methodology. Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook (March 2023).