U. S. The Food and Drug Administration (FDA) aims in the following order:
"The FDA is responsible for protecting public health by ensuring the safety, efficacy and safety of human and veterinary drugs, biological products, medical devices, our nation with food, cosmetics and products, emissions. The FDA is also responsible for promoting health procurement, innovation and speed FOOD MARKET drug effective, safe and accessible, and public support, accurate scientific information they need medicine and food to improve their health. "
In 2005 the FDA that the draft guidelines for the pharmaceutical industry to develop drugs for the treatment of acne vulgaris, or acne. The Project Guide includes the reflections diFDA for the development of acne medication and usedmethods.
Some guidelines are summarized Infosrmation Riashieronder. At the time of writing this document the FDA had not yet been completed.
Types of acne lesions
The two main types of acne lesions are inflammatory and non-steroidal inflammatory drugs. The non-inflammatory acne peausont changes commonly known as Whitehead and comedones. Infiammatoriedi acne lesions are papules and pustules and deeper into the skin lesions are not inflammatory.
How assess the severity of acne
There is currently no metodBombardier or standard assessment of the severity of acne break outs. Several methods have been proposed, but each has its problems. A reference sample for assessing the severity of acne are summarized below, the countries peution for the worst:
0 San disponibilis inflammatory skin lesions or non-steroidal inflammatory drugs
1 FAST clearly not rare inflammatory lesions no more than a clothingin inflammatory lesions
2 small, more than 1 degree, no injuries inflamestorie not more than a few inflammatory lesions (papules / pustules, nødder no injuries)
3 the severity of fashion, more than 2 degrees, with several non-inflammatory lesions and inflammatory lesions ment in May, but no more than one nodular lesion piccolote
4 * severity greater than 3 degrees, with many non-inflammatory and inflammatory lesions, but no more than a few injuries nodularity
(* Reduction of footnote 4 is also possible).
Acne Therapy Study Groups
Acne medication groups and observations is large enough to test statistically significant, so that recourse to the success and safety can be maintained. Test patients were recruited normally in the course of their severe acne breakout bricks.
Acne medication recommended verblindete randomized multicenter studies, and other conditions also apply. A control gcall or placebo.
Moreover, tests of evidence in public, representatives of the age, race, geographic location and sessof patients with acne in the United States.
The success of acne treatment drug
AkneSchwere is the beginning and end of ogniprocesso. Photographic evidence and / or injury shall be taken.. It is proposed that the success of acne medication is considered a success or a failure, according to one of the two methOden to measure success:
1. Good luck, a clear assessment of the skin, or almost (Average severity 0 or 1) or in test
2nd SuccesIn the meaning of an improvement of 2 degrees of severity of Test Phase. According to this definition is a successoil control would improve the severity of 4-2 in the test phase, as an example.
The final decision on new acne drug
Different stages of the research is recommended for acne, the drug. The studies should beand the effects such as the interruption of the test. Analytical rigor must comply with the rules of the FDA. Only the acne drug testdat the data are validated and quality must be submitted to the FDA for a license.
Only through a strict and strictly controlled testing and analysis of the procedure followed by the FDA, the new acne medicines are available to the public.
Resources link contains free information on how youoptimum use of FDA-mail and OTC acne medications and treatments.
Source: Guidance for Industry, acne vulgaris: The development of drugs for trattamento, Design, U. S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and resucita (CDER), September 2005, clinical / medical.
"The FDA is responsible for protecting public health by ensuring the safety, efficacy and safety of human and veterinary drugs, biological products, medical devices, our nation with food, cosmetics and products, emissions. The FDA is also responsible for promoting health procurement, innovation and speed FOOD MARKET drug effective, safe and accessible, and public support, accurate scientific information they need medicine and food to improve their health. "
In 2005 the FDA that the draft guidelines for the pharmaceutical industry to develop drugs for the treatment of acne vulgaris, or acne. The Project Guide includes the reflections diFDA for the development of acne medication and usedmethods.
Some guidelines are summarized Infosrmation Riashieronder. At the time of writing this document the FDA had not yet been completed.
Types of acne lesions
The two main types of acne lesions are inflammatory and non-steroidal inflammatory drugs. The non-inflammatory acne peausont changes commonly known as Whitehead and comedones. Infiammatoriedi acne lesions are papules and pustules and deeper into the skin lesions are not inflammatory.
How assess the severity of acne
There is currently no metodBombardier or standard assessment of the severity of acne break outs. Several methods have been proposed, but each has its problems. A reference sample for assessing the severity of acne are summarized below, the countries peution for the worst:
0 San disponibilis inflammatory skin lesions or non-steroidal inflammatory drugs
1 FAST clearly not rare inflammatory lesions no more than a clothingin inflammatory lesions
2 small, more than 1 degree, no injuries inflamestorie not more than a few inflammatory lesions (papules / pustules, nødder no injuries)
3 the severity of fashion, more than 2 degrees, with several non-inflammatory lesions and inflammatory lesions ment in May, but no more than one nodular lesion piccolote
4 * severity greater than 3 degrees, with many non-inflammatory and inflammatory lesions, but no more than a few injuries nodularity
(* Reduction of footnote 4 is also possible).
Acne Therapy Study Groups
Acne medication groups and observations is large enough to test statistically significant, so that recourse to the success and safety can be maintained. Test patients were recruited normally in the course of their severe acne breakout bricks.
Acne medication recommended verblindete randomized multicenter studies, and other conditions also apply. A control gcall or placebo.
Moreover, tests of evidence in public, representatives of the age, race, geographic location and sessof patients with acne in the United States.
The success of acne treatment drug
AkneSchwere is the beginning and end of ogniprocesso. Photographic evidence and / or injury shall be taken.. It is proposed that the success of acne medication is considered a success or a failure, according to one of the two methOden to measure success:
1. Good luck, a clear assessment of the skin, or almost (Average severity 0 or 1) or in test
2nd SuccesIn the meaning of an improvement of 2 degrees of severity of Test Phase. According to this definition is a successoil control would improve the severity of 4-2 in the test phase, as an example.
The final decision on new acne drug
Different stages of the research is recommended for acne, the drug. The studies should beand the effects such as the interruption of the test. Analytical rigor must comply with the rules of the FDA. Only the acne drug testdat the data are validated and quality must be submitted to the FDA for a license.
Only through a strict and strictly controlled testing and analysis of the procedure followed by the FDA, the new acne medicines are available to the public.
Resources link contains free information on how youoptimum use of FDA-mail and OTC acne medications and treatments.
Source: Guidance for Industry, acne vulgaris: The development of drugs for trattamento, Design, U. S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and resucita (CDER), September 2005, clinical / medical.
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