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Is the customer always right when deciding on the timing of API process research?

corresponding

ALAN HARRIS1*, DAVID LATHBURY2, DAVID ENNIS3
*Corresponding author
1. Alacrity Pharma Associates
2. AMRI in 21 Corporate Circle, Albany, NY 12203-5154, USA
3. AstraZeneca, Macclesfield, Cheshire, SK10 4TF, United Kingdom

INTRODUCTION
The synthetic methods used by the medicinal chemist are typically designed for diversity and as such are only rarely capable, at least without further development, of meeting the initial aim of any programme to provide material for development studies. It is even rarer that these methods provide the optimum synthetic route for commercialisation purposes. Yet both large and small R&D organisations often ignore this issue during the early development phases and simply scale-up the Medicinal chemistry methods. In this article we will explore why this is and why this mind-set should change if a company is to reduce costs in development and provide opportunities for more cost effective products for payers.

THE TIME TO THINK
To the inexperienced, the value of the chemical route selection and development component of a project may only become clear at the point when the drug is approaching validation and commercialization. Unfortunately, remedial action at this stage, although possible, is unpredictable because a late route change may affect other critical quality aspects, e.g. formulation and stability. Making a cha ...
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