Sentence examples for clinical development plans from inspiring English sources
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.
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.
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.
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.
The clinical development plans for F8-IL10 alsoalso justified by the excellent tolerability profile observed in rodents and monkeys.
Kellof G, Crowell J, Boone C, Steele V, Lubet R, Greenwald P, et al. Clinical development plan: tamoxifen.
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.
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.
