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Product Development For An Oral Solid Dosage Using Continuous Manufacturing
Source: Thermo Fisher Scientific
By Kiernan LaMarche and Jessica Settimi, Thermo Fisher
When bringing a new drug to market, product development is typically aligned with the clinical trial schedule; therefore, as the patient pool grows, so does the supply of drugs needed for the study. Phase I calls for a small trial formulation using the easiest and least expensive manufacturing methods for just getting the drug to the patient. Once you move into Phase II, a prototype batch process is often most cost effective, especially since most drug candidates do not make it past this stage.