Tag: project. TPP

Emerging TPPs  As a drug moves through development its properties, activity and effect on disease are revealed. ETPPs are used to summarize these aspects for the drug given the current understanding of the drug’s performance and how they align with the critical elements of the Aspirational TPPs.   ETPPs typically describe the value critical aspects of the drug from the developer’s perspective - which may be the potential usage and uptake in patients for a commercial drug developer, or how the drug can enable access to hard to reach neglected diseases from a not-for-profit drug developer, or even how the approach may drive the science in a new area and foster innovation from a more academically focussed developer. ETPPs should cross reference the critical requirements of the ATPPs, unless the drug in question is in a new and unexpected area where no ATPP exists. Some examples of the elements of ETPPs are:   Efficacy and toleration profile   Number of hospital days saved   Sttability data for the formulation...