Regulatory requirement - Revision history

wikademia>Wikademia at 21:52, 26 April 2009

2009-04-26T21:52:48Z

← Older revision		Revision as of 21:52, 26 April 2009
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	[[Category:clinical research]]		[[Category:clinical research]]
	[[Category:Pharmaceuticals policy]]		[[Category:Pharmaceuticals policy]]

	~~[[ru:Специалист по клиническим исследованиям]]~~

wikademia>Wikademia at 21:52, 26 April 2009

2009-04-26T21:52:32Z

← Older revision		Revision as of 21:52, 26 April 2009
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	These systems of new drug approvals are extremely rigorous and costly. On average, it will cost a pharmaceutical company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the [[Congressional Office of Technology Assessment]]. It takes 12 years on average for an experimental [[approved drug\|drug]] to travel from the laboratory to the medicine chest. Only five in 5,000 compounds that enter preclinical testing will actually progress into human clinical trials, and of these five, only one is likely to be approved by the regulatory authorities.		These systems of new drug approvals are extremely rigorous and costly. On average, it will cost a pharmaceutical company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the [[Congressional Office of Technology Assessment]]. It takes 12 years on average for an experimental [[approved drug\|drug]] to travel from the laboratory to the medicine chest. Only five in 5,000 compounds that enter preclinical testing will actually progress into human clinical trials, and of these five, only one is likely to be approved by the regulatory authorities.
			{{ntnes}}
	== Drug Discovery and Development ==		== Drug Discovery and Development ==
	The process of [[drug discovery]] and development begins with improvements in the understanding of disease. Basic scientific research will identify new biological targets which may be amenable to chemical alteration (e.g., to inhibit or stimulate an important [[enzyme]], to alter a metabolic pathway, or to change cellular structure). [[New chemical entities]] (NCEs) can be produced through novel chemical synthesis or extracted from natural sources (plant, mineral, or animal). The number of compounds that can be produced based on the same general [[chemical]] structure (or "[[pharmacophore]]") can run into the millions.		The process of [[drug discovery]] and development begins with improvements in the understanding of disease. Basic scientific research will identify new biological targets which may be amenable to chemical alteration (e.g., to inhibit or stimulate an important [[enzyme]], to alter a metabolic pathway, or to change cellular structure). [[New chemical entities]] (NCEs) can be produced through novel chemical synthesis or extracted from natural sources (plant, mineral, or animal). The number of compounds that can be produced based on the same general [[chemical]] structure (or "[[pharmacophore]]") can run into the millions.

wikademia>Wikademia: 55 revisions

2009-04-18T16:13:31Z

55 revisions

← Older revision	Revision as of 16:13, 18 April 2009
(No difference)

wikademia>Sceptre: Reverted edits by 220.227.67.171 to last version by Reyk (HG)

2009-01-05T04:37:43Z

Reverted edits by 220.227.67.171 to last version by Reyk (HG)

← Older revision		Revision as of 04:37, 5 January 2009
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	== Regulatory Review: New Drug Application (NDA) ==		== Regulatory Review: New Drug Application (NDA) ==
	An application to the FDA for ~~dfgfghfmbn~~ approval to market a new drug. All information about the drug gathered during the drug discovery and development process is assembled in the [[New Drug Application]] (NDA). During the review period, the FDA may ask the company for additional ~~informvbgjgyf ation~~ about ~~th e produc t~~ or seek ~~gfhf~~ clarification of the data contained in the application.		An application to the FDA for approval to market a new drug. All information about the drug gathered during the drug discovery and development process is assembled in the [[New Drug Application]] (NDA). During the review period, the FDA may ask the company for additional information about the product or seek clarification of the data contained in the application.

	== Post approval ==		== Post approval ==

220.227.67.171: /* Regulatory Review: New Drug Application (NDA) */

2009-01-05T04:36:31Z

Regulatory Review: New Drug Application (NDA)

← Older revision		Revision as of 04:36, 5 January 2009
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	== Regulatory Review: New Drug Application (NDA) ==		== Regulatory Review: New Drug Application (NDA) ==
	An application to the FDA for approval to market a new drug. All information about the drug gathered during the drug discovery and development process is assembled in the [[New Drug Application]] (NDA). During the review period, the FDA may ask the company for additional ~~information~~ about ~~the product~~ or seek clarification of the data contained in the application.		An application to the FDA for dfgfghfmbn approval to market a new drug. All information about the drug gathered during the drug discovery and development process is assembled in the [[New Drug Application]] (NDA). During the review period, the FDA may ask the company for additional informvbgjgyf ation about th e produc t or seek gfhf clarification of the data contained in the application.

	== Post approval ==		== Post approval ==

wikademia>Reyk: avoid disambig

2008-12-27T03:49:20Z

avoid disambig

← Older revision		Revision as of 03:49, 27 December 2008
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	===Phase 1 Clinical Evaluation===		===Phase 1 Clinical Evaluation===
	The first testing of a new compound in human subjects, for the purpose of establishing the tolerance of healthy human subjects at different doses, defining its pharmacological effects at anticipated therapeutic levels, and studying its [[absorption]], distribution, [[metabolism]], and excretion patterns in humans ([[ADME]]).		The first testing of a new compound in human subjects, for the purpose of establishing the tolerance of healthy human subjects at different doses, defining its pharmacological effects at anticipated therapeutic levels, and studying its [[absorption (pharmacokinetics)\|absorption]], distribution, [[metabolism]], and excretion patterns in humans ([[ADME]]).

	===Phase 2 Clinical Evaluation===		===Phase 2 Clinical Evaluation===

wikademia>Plumpurple: that tag doesn t work

2008-11-27T22:55:18Z

that tag doesn t work

← Older revision		Revision as of 22:55, 27 November 2008
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	~~{{POV}}~~'''Regulatory requirements''' are part of the process of [[drug discovery]] and [[drug development]]. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the [[Food and Drug Administration]] (FDA) to establish these regulatory requirements. The [[European Medicines Agency]] (EMEA) and Japanese [[Japan Ministry of Health\|Pharmaceuticals and Medical Devices Agency]] (PMDA) are also important regulatory authorities in drug development. These three agencies oversee the three largest markets for drug sales.		'''Regulatory requirements''' are part of the process of [[drug discovery]] and [[drug development]]. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the [[Food and Drug Administration]] (FDA) to establish these regulatory requirements. The [[European Medicines Agency]] (EMEA) and Japanese [[Japan Ministry of Health\|Pharmaceuticals and Medical Devices Agency]] (PMDA) are also important regulatory authorities in drug development. These three agencies oversee the three largest markets for drug sales.

	Historically, the various regulatory authorities have had their own methods for obtaining regulatory approval, however the rising cost of meeting the demands of differing regulations led to the establishment of an [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH) in an attempt to co-ordinate and synthesize international regulatory requirements. The first Conference was held in [[Brussels]] in 1991, followed by ICH 2 in [[Orlando, Florida]] in 1993, and ICH 3 in [[Yokohama]], Japan in 1995. The Fourth International Conference on Harmonisation, in July 1997, was once again in Brussels.		Historically, the various regulatory authorities have had their own methods for obtaining regulatory approval, however the rising cost of meeting the demands of differing regulations led to the establishment of an [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH) in an attempt to co-ordinate and synthesize international regulatory requirements. The first Conference was held in [[Brussels]] in 1991, followed by ICH 2 in [[Orlando, Florida]] in 1993, and ICH 3 in [[Yokohama]], Japan in 1995. The Fourth International Conference on Harmonisation, in July 1997, was once again in Brussels.

wikademia>Plumpurple: Scope of this article is much too narrow for this subject which applies to all aspects of environment, safety, energy etc

2008-11-27T22:54:29Z

Scope of this article is much too narrow for this subject which applies to all aspects of environment, safety, energy etc

← Older revision		Revision as of 22:54, 27 November 2008
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	'''Regulatory requirements''' are part of the process of [[drug discovery]] and [[drug development]]. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the [[Food and Drug Administration]] (FDA) to establish these regulatory requirements. The [[European Medicines Agency]] (EMEA) and Japanese [[Japan Ministry of Health\|Pharmaceuticals and Medical Devices Agency]] (PMDA) are also important regulatory authorities in drug development. These three agencies oversee the three largest markets for drug sales.		{{POV}}'''Regulatory requirements''' are part of the process of [[drug discovery]] and [[drug development]]. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the [[Food and Drug Administration]] (FDA) to establish these regulatory requirements. The [[European Medicines Agency]] (EMEA) and Japanese [[Japan Ministry of Health\|Pharmaceuticals and Medical Devices Agency]] (PMDA) are also important regulatory authorities in drug development. These three agencies oversee the three largest markets for drug sales.

	Historically, the various regulatory authorities have had their own methods for obtaining regulatory approval, however the rising cost of meeting the demands of differing regulations led to the establishment of an [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH) in an attempt to co-ordinate and synthesize international regulatory requirements. The first Conference was held in [[Brussels]] in 1991, followed by ICH 2 in [[Orlando, Florida]] in 1993, and ICH 3 in [[Yokohama]], Japan in 1995. The Fourth International Conference on Harmonisation, in July 1997, was once again in Brussels.		Historically, the various regulatory authorities have had their own methods for obtaining regulatory approval, however the rising cost of meeting the demands of differing regulations led to the establishment of an [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]] (ICH) in an attempt to co-ordinate and synthesize international regulatory requirements. The first Conference was held in [[Brussels]] in 1991, followed by ICH 2 in [[Orlando, Florida]] in 1993, and ICH 3 in [[Yokohama]], Japan in 1995. The Fourth International Conference on Harmonisation, in July 1997, was once again in Brussels.

wikademia>CrazyChemGuy: clean up using AWB

2008-05-26T00:25:31Z

clean up using AWB

← Older revision		Revision as of 00:25, 26 May 2008
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	[[Category:Pharmaceuticals policy]]		[[Category:Pharmaceuticals policy]]

	[[ru:Специалист по клиническим исследованиям]		[[ru:Специалист по клиническим исследованиям]]

wikademia>Pseudomonas: Reverted edits by 121.23.181.200 to last version by 67.177.237.161

2008-04-26T13:08:55Z

Reverted edits by 121.23.181.200 to last version by 67.177.237.161

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