Paul Van Tilborg is director of analytical sciences at Ardena.

Paul Van Tilborg

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).

Pharmaceutical Technology's March 2023 Quality and Regulatory Sourcebook eBook

When referring to this article, please cite it as Van Tilborg, P. Phase-appropriate Analytical Methodology. 

Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook 

Articles

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