Proof of principle studies

@article{Schmidt2006ProofOP,
  title={Proof of principle studies},
  author={Bernd Schmidt},
  journal={Epilepsy Research},
  year={2006},
  volume={68},
  pages={48-52}
}
  • B. Schmidt
  • Published 31 January 2006
  • Psychology
  • Epilepsy Research
View on Elsevier
doi.org
60 Citations
Highly Influential Citations
3
Background Citations
19
Methods Citations
9
Results Citations
1

60 Citations

Frameworks for Proof-of-Concept Clinical Trials of Interventions That Target Fundamental Aging Processes
TLDR
This article summarizes the outcomes of an international meeting partly funded through the NIH R24 Geroscience Network, whose purpose was to generate concepts and frameworks for early, proof-of-concept clinical trials for therapeutic interventions that target fundamental processes of aging.
A Bayesian Method for the Detection of Proof of Concept in Early Phase Oncology Studies with a Basket Design
TLDR
A novel approach for PoC detection in the early phase basket trials under a Bayesian framework is proposed, and results show that the proposed approach has a promising performance, with considerable gain in power compared with the independent approach when a relatively large number of the cancer types are sensitive to the treatment.
Proof‐of‐Principle/Proof‐of‐Concept Trials in Drug Development
TLDR
The biomarkers, pharmacogenomics, proteomics, metabonomics, medical imaging, pharmacological models, and nonpharmacological models in PoP/PoC trials are focused on.
Exenatide and the treatment of patients with Parkinson's disease.
TLDR
These results demonstrate a potential cost-efficient approach through which preliminary clinical data of possible biological effects are obtainable, prior to undertaking the major investment required for double-blind trials of a potential disease-modifying drug in PD.
Clinical development of antiepileptic drugs in adults
  • B. Schmidt
  • Medicine, Psychology
    Neurotherapeutics
  • 2011
How predictive are photosensitive epilepsy models as proof of principle trials for epilepsy?
Exenatide as a novel treatment for Parkinson's Disease
TLDR
The aim of this thesis is the evaluation of Exenatide’s possible role as a potential neuroprotective/disease modifying agent in PD with only preliminary insights regarding its mechanisms of action in neurodegeneration.
Drugs’ development in acute heart failure: what went wrong?
TLDR
This review has reviewed the data published on drugs developed for AHF since early 2000s, trying to recognise factors that have worked for a successful approval or for the stoppage of the program, in an attempt to delineate future trajectories forAHF drug development.
Efficacy of the histamine 3 receptor (H3R) antagonist pitolisant (formerly known as tiprolisant; BF2.649) in epilepsy: Dose-dependent effects in the human photosensitivity model
Efficacy and Safety of Pirfenidone in Patients with Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
TLDR
A decrease in wound healing time by enhancing wound re-epithelialization was observed with pirfenidone, and Histologic evaluations showed less wound fibrosis in the pirfenodone group.
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References

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    Epilepsy Research
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A complete withdrawal of AEDs should be avoided and a titration phase limited to 3 days is suggested, using a condensed evaluation setting including the TISA method, serum concentration and neuropsychological monitoring, by which AED efficacy on seizure activity can be objectively quantified by using continuous video‐EEG monitoring.
Photosensitive epilepsy: a model to study the effects of antiepileptic drugs. Evaluation of the piracetam analogue, levetiracetam
A randomised double-blind placebo-controlled crossover add-on trial of lamotrigine in patients with treatment-resistant partial seizures
Transcranial magnetic stimulation (TMS)
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Lactate and Other Metabolic Changes in Neuronal Migration Disorders