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4 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March eBook 2023 PharmTech.com MURRSTOCK - STOCK.ADOBE.COM P rogressing 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 stra- tegic planning or a lack of commercial needs (2). Highlighting solid strategy and funding alone is not enough to take a drug to market. Approx- imately 70–80% of clinical failures can be at- tributed 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). There are many strategies that are employed to optimize the return on investment; one of which is simply to avoid overspending in early develop- ment, which is enabled by effective and structured development of chemical and analytical processes throughout drug development. The importance of quality-consistent material throughout development Synthesis development and associated analy tical procedure development are the starting points for every new pharmaceutical product entering the de- velopment phase. The development phase occurs under huge time-pressure, as (pre)clinical material is required as soon as possible to reach the next mile- stone. Yet, developing a new route for batches in de- velopment is nearly always preferred over continua- tion with the 'research route' because: • (Pre)clinical development studies require much larger amounts of the drug candidate than are required during t he research phase. T he 're- search route' of ten has a design or contains Phase-appropriate Analytical Methodology Paul Van Tilborg is director of analytical sciences at Ardena. A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.