Criteria for Progression

In terms of program management, drug discovery for DDW is no different from drug discovery for first-world diseases. Programs should identify clear objectives and well-defined criteria for progression toward the clinical candidate, which is often formally defined in the TPPs. Drug PDPs (e.g., MMV, TB Alliance, DNDi) have TPP definitions for their programs in their respective web pages (Table 4). Criteria for lead progression have recently been discussed [179]. A clinical candidate typically meets most, though not necessarily all, of the criteria as defined by the TPP, including in vivo efficacy in animal models, good potency and duration of action, acceptable route of administration (usually PO), a well-defined PK/PD relationship, and, based on human in vitro properties and animal models, good predicted human PK properties.

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