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Phases of Clinical Trials

Phases of Clinical Trials

Phases of clinical trials.
Phase 0 Phase 0 is a recent designation for exploratory, first-in-human trials conducted in accordance with the United States Food and Drug Administration’s (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single sub therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent’s pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.

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10 Best Startup Accelerators

10 Best Startup Accelerators

Y Combinator is a pioneer in the startup accelerator space. Each year the accelerator funds a group of new startups with $120k. A number that was lowered to reduce friction between founders. So far, the companies it has been involved with have a combined valuation of...

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The Top 100 VCs in US biotechs

The Top 100 VCs in US biotechs

Where the money is: The top 100(+) VCs investing in U.S. biotechs Warning: Read this before looking at the sortable list below. (No, I mean it. Stop.) Bioregnum by John Carroll 2015 proved to be the biggest year on record for venture investing in U.S. biotechs. A...

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Dietary Supplement Greatly Extends Worm Life Span

Dietary Supplement Greatly Extends Worm Life Span

Drug seems to mimic the biological effects of calorie restriction, letting worms live up to 70 percent longer. By Virginia Hughes, for National Geographic PUBLISHED MAY 14, 2014 A light micrograph of Caenorhabditis elegans, a soil-dwelling nematode often used in...

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Targets for future drugs of AD

Targets for future drugs of AD

The hope for future drugs Currently, there are five FDA-approved Alzheimer's drugs that treat the symptoms of Alzheimer's — temporarily helping memory and thinking problems — with a sixth drug available globally. But these medications do not treat the underlying...

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HUP on memory in AD

HUP on memory in AD

Efficacy of tablet huperzine-A on memory, cognition, and behavior in Alzheimer's disease. Abstract AIM: To evaluate the efficacy and safety of tablet huperzine-A (Hup) in patients with Alzheimer's disease. METHODS: Using multicenter, prospective, double-blind,...

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Neurotrope – Alzheimer’s trial Phase 2

Neurotrope – Alzheimer’s trial Phase 2

Neurotrope misses primary endpoint in Alzheimer’s trial by Nick Paul Taylor | May 1, 2017 6:59am A phase 2 trial of Neurotrope’s Alzheimer’s disease candidate has missed its primary endpoint. The study set out to show bryostatin improved performance on a...

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