During the drug development process there are many critical milestones and many more potential pitfalls which could seriously impact the timely progression of a new compound into the next phase. One of the major milestones is the entry into clinical phase 1, where a new compound is administered to healthy subjects for the first time. The greatest challenges arise from the fact that both the synthesis and characterization of the drug substance is still limited and yet clinical material must be produced and released for use in humans. For clinical trials the drug must be converted into a form that has sufficient stability and bioavailability, and at the same time can be provided in an administrable form of different dose strengths. However there are multiple drug characteristics (table 1) which might prevent or at least challenge the provision of clinical materials of an orally administered drug compound for the first in human trials.
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