Clinical testing - Revision history

Frodo: asdf

2015-08-16T19:52:39Z

asdf

← Older revision		Revision as of 19:52, 16 August 2015
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	In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.		In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.


			<pre>
			http://zinc15.docking.org/trials/subsets/depression+2010s+current/

			http://zinc15.docking.org/trials/subsets/current/?drug_names-match=risperidone

			http://zinc15.docking.org/trials/subsets/cancer+2010s/

			http://zinc15.docking.org/trials/subsets/cancer+2010s/?sort=-num_substances

			http://zinc15.docking.org/trials/subsets/current/?substances-any-names=mtx

			http://zinc15.docking.org/trials/subsets/depression+current/?substances-any-names=abilify

			http://zinc15.docking.org/trials/?year-between=2013,2015&intervention_names-match=domperidone

			http://zinc15.docking.org/trials/subsets/current+phase-iii/?intervention_names-match=Olanzapine

			http://zinc15.docking.org/trials/NCT02116530/

			</pre>

	[[Category:Jargon]]		[[Category:Jargon]]

Frodo at 17:07, 14 February 2014

2014-02-14T17:07:26Z

← Older revision		Revision as of 17:07, 14 February 2014
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	[[Category:~~Docktionary]]~~		[[Category:Jargon]]
	~~[[Category:FDA~~]]

Frodo at 18:20, 21 October 2012

2012-10-21T18:20:54Z

← Older revision		Revision as of 18:20, 21 October 2012
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	[[Category:~~Jargon~~]]		[[Category:Docktionary]]
	[[Category:FDA]]		[[Category:FDA]]

Therese: 5 revisions

2012-10-08T18:10:31Z

5 revisions

← Older revision	Revision as of 18:10, 8 October 2012
(No difference)

JohnIrwin at 20:28, 20 September 2007

2007-09-20T20:28:35Z

← Older revision		Revision as of 20:28, 20 September 2007
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	In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.		In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.


			[[Category:Jargon]]
			[[Category:FDA]]

Frodo at 13:52, 13 September 2007

2007-09-13T13:52:51Z

← Older revision		Revision as of 13:52, 13 September 2007
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	Clinical testing or clinical trials is the long and expensive process of investigating whether a drug candidate is suitable to become a drug.		Clinical testing or clinical trials is the long and expensive process of investigating whether a drug candidate is suitable to become a drug.

	In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).		In the US, this process is supervised and regulated by the Food and Drug Administration ([[FDA]]).

	Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. Before clinical trials can begin, the compound is registered as an [[investigational new drug]] (IND) with the FDA.		Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. Before clinical trials can begin, the compound is registered as an [[investigational new drug]] (IND) with the FDA.

Frodo at 13:50, 13 September 2007

2007-09-13T13:50:12Z

← Older revision		Revision as of 13:50, 13 September 2007
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	Clinical testing in the long and expensive process of investigating whether a drug candidate is suitable to become a drug.		Clinical testing or clinical trials is the long and expensive process of investigating whether a drug candidate is suitable to become a drug.

	In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).		In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).

Frodo at 13:47, 13 September 2007

2007-09-13T13:47:58Z

← Older revision		Revision as of 13:47, 13 September 2007
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	In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).		In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).

	Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:		Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions. Before clinical trials can begin, the compound is registered as an [[investigational new drug]] (IND) with the FDA.

	In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.		In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
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	In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.		In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

			Successful completion of Phase III results in a [[new drug application]] (NDA) which can be marketed (and, importantly, sold).

	In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.		In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

	In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.		In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.

Frodo at 13:45, 13 September 2007

2007-09-13T13:45:16Z

New page

Clinical testing in the long and expensive process of investigating whether a drug candidate is suitable to become a drug.

In the US, this process is supervised and regulated by the Food and Drug Administration (FDA).

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

In practice, Phase IV trials are rarely followed through because they are often not mandatory. Special rules apply to [[orphan drug]] trials.