Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline. Addressing this potential roadblock to clinical success is becoming increasingly important as NCEs continue to become larger and more lipophilic and, as a result, less soluble.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how the company’s product is worth the investment by protecting products and patients.
The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
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Terry Katz, CEO and cofounder of ForgeStop Technology Corporation, explains the company’s CPHI Award-winning connected product technology and how it helps to combat drug counterfeiting.