Sentence examples for clinical development plan from inspiring English sources

Kellof G, Crowell J, Boone C, Steele V, Lubet R, Greenwald P, et al. Clinical development plan: tamoxifen.

There was also discussion of when these studies are needed in relation to the clinical development plan.

A clinical development plan specific to children is a necessary component of every development plan for a new antiepileptic drug (AED).

These data are generated from a global clinical development plan which was designed a long time before the new medicine's submission for reimbursement.

The availability of accurate intravenous (iv) PK and human absorption, distribution, metabolism, and excretion (ADME) information, even before or during Phase I trials, can improve the clinical development plan.

Furthermore, sex-gender-specific pre-clinical pharmacological testing will enable adequate assessment of pharmacokinetic and pharmacodynamic actions of drugs and will enable, where appropriate, an adequate gender-specific clinical development plan.

The consultation also considered the regulatory requirements for registration of a malaria vaccine and public health issues that clinical development plans need to address before deployment of a malaria vaccine in developing countries.

The diversity of risk in populations needs to be factored into clinical development plans, specific but feasible clinical endpoints need to be agreed upon, and TB vaccines need to be effective in both uninfected and infected populations.

The original biomarker classification has been further modified into a translational biomarker scheme that is used as a communication tool for drug hunting teams to guide designing translational and early clinical development plans as part of an integrated model-informed drug discovery and development strategy.

We have compared three clinical development plans for a time-to-event endpoint, such as overall survival, that all lead to a decision in a pivotal trial either in all comers only, in allcomers and biomarker positive, in the biomarker positive only, or to declare the drug futile.

In addition to possible effects on transmission, vaccine developers would also be interested in determining whether substantial herd immunity effects are likely, and thus clinical development plans need to evaluate effects on transmission to the vector.