Clinical trials in neurology : design, conduct, analysis by Bernard Ravina; et al

By Bernard Ravina; et al

''Translating laboratory discoveries into profitable therapeutics will be tricky. scientific Trials in Neurology goals to enhance the potency of medical trials and the advance of interventions with a purpose to improve the improvement of recent remedies for neurologic illnesses. It introduces the reader to the major options underpinning trials within the neurosciences. This quantity tackles the demanding situations of developing Read more...

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Conidence in the accuracy of the safety 14 and tolerability proile is derived from the number of patients exposed and their duration of treatment with a medication. For chronically administered drugs for non-life threatening conditions, the International Committee on Harmonisation (ICH) Guidelines recommend an overall exposure of 1500 patients with 300–600 patients exposed for 6 months and 100 patients exposed for one year [16]. hese exposures must occur at the dose or dose range believed to be eicacious.

Lancet Neurol 2008; 7: 84–96. Chapter 3: Unique challenges in the development of therapies 18. Rambeck B, Jurgens UH, May TW, et al. Comparison of brain extracellular luid, brain tissue, cerebrospinal luid, and serum concentrations of antiepileptic drugs measured intraoperatively in patients with intractable epilepsy. Epilepsia 2006; 47: 681–94. 19. Norinder U and Haeberlein M. Computational approaches to the prediction of the blood-brain distribution. Adv Drug Deliv Rev 2002; 54: 291–313. 20. Lohmann C, Huwel S, and Galla HJ.

Brain-to-blood transporters for endogenous substrates and xenobiotics at the bloodbrain barrier: an overview of biology and methodology. NeuroRx 2005; 2: 63–72. 15. Loscher W and Potschka H. Blood-brain barrier active elux transporters: ATP-binding cassette gene family. NeuroRx 2005; 2: 86–98. 16. Patel MM, Goyal BR, Bhadada SV, et al. Getting into the brain: approaches to enhance brain drug delivery. CNS Drugs 2009; 23: 35–58. 17. Neuwelt E, Abbott NJ, Abrey L, et al. Strategies to advance translational research into brain barriers.

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