Quality and Regulatory Sourcebook eBook
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Phase-appropriate Analytical Methodology
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BioPharm International’s Quality and Regulatory Sourcebook eBook
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 the article:
Phase-appropriate Analytical Methodology
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BioPharm International’s Quality and Regulatory Sourcebook eBook
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Paul Van Tilborg is director of analytical sciences at Ardena.
BioPharm International
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. BioPharm International’s Quality and Regulatory Sourcebook eBook (March 2023).
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