By K.M. Woodbury-Harris, B.M. Coull, J. Bogousslavsky
A competently designed and accomplished scientific trial that addresses an import query and offers a definitive outcome can swap the perform of drugs around the world. This ebook contains a bench-to-bedside procedure and serves as a very good advice for translating preclinical reviews to early section I/II and part III trials. within the first half, the booklet covers preclinical technology with recognize to animal versions of assorted neurological ailments, FDA standards for preclinical reports, translation of animal to sufferer reviews and scaling up from animal to human reviews. within the moment half, the layout of section I/II trials and using biomarkers as surrogate endpoints are mentioned. in regards to section III trials, FDA and ecu standards, particular layout matters, suitable medical endpoints in addition to info administration and caliber are tested. themes particular to multicenter trials, equivalent to layout, recruitment of particular populations, tracking, moral and consent concerns also are lined. eventually, genetics, gene treatment, imaging and surgical units are reviewed. This book is very prompt to clinician researchers, corresponding to neurologists, neurosurgeons, pediatric neurologists and neonatologists, who are looking to layout and behavior scientific trials within the neuroscience, but additionally to nurses, study coordinators and scientific pharmacologists.
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Extra info for Clinical Trials in the Neurosciences (Frontiers of Neurology and Neuroscience)
For the induction of focal TBIs, a controlled cortical impact model is widely used in either rats or mice and involves the infliction of a contusion injury through a small craniotomy. 0 mm in rats). The controlled cortical impact model mimics TBI-induced brain contusions, although a recent study has shown that the subsequent neurodegeneration is not as focal as generally thought . A relatively new in vivo model utilizing a controlled stretch of the optic nerve in mice has been developed to examine the effects of stretch injury on axons.
6 A comparison of the neurorestorative pharmacology and cellular therapy (doseresponse, optimum treatment duration and therapeutic window) in multiple injury models (focal vs. diffuse TBI) is required in order to determine whether the agent in question only works in certain types of injuries. 7 A comparison of the neurorestorative approach in male versus female animals is needed. 8 A determination of pharmacodynamic and pharmacokinetic interactions with other commonly used ancillary treatments (anticonvulsants, minor and major tranquilizers) should be undertaken.
The primary endpoints are generally behavioral and in motor or neurological function typically determined between 24 and 72 h after stroke onset, and sometimes after longer periods of time. However, MCAO models have been developed and are occasionally used in higher species including the cat, monkey and baboon; the use of these animal models for neuroprotective drug evaluation carries considerable expense. Some investigators believe that it is important to replicate pharmacological neuroprotective actions in these gyrencephalic species prior to movement of the compound into human clinical trials.