Early stage manufacturers of oral solid dosage forms need to be fast and flexible to generate development pathways that can cope with variable API characteristics, as well as highly potent molecules.
Technology, risk assessment, quality by design and scale-up to later-phase studies are all in the mix of considerations.
No two early development projects are alike. The active pharmaceutical ingredient (API) properties will differ, from the potency to the physical characteristics; the clinical plans will vary, from the locations, to the study centres, to the design of the study itself.
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This article originally appeared in European Biopharmaceutical Review.
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