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Reply: Oxycodone vs. Oxycodone HCL- same thing?

http://frontiernet.net

All from the FDA website on generics: Generics are not required to replicate the...

Posted by Peskypain

http://frontiernet.net

All from the FDA website on generics:

Generics are not required to replicate the extensive clinical trials that have already been used in the development of the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients.

Since the safety and efficacy of the brand-name product has already been well established in clinical testing and frequently many years of patient use, it is scientifically unnecessary, and would be unethical, to require that such extensive testing be repeated in human subjects for each generic drug that a firm wishes to market. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner) to the pioneer drug.

One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers.

This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug.

As well as some common Myths about generics:

MYTH: Generics take longer to act in the body.

FACT: The firm seeking to sell a generic drug must show that its drug delivers the same amount of active ingredient in the same timeframe as the original product.

MYTH: Generics are not as potent as brand-name drugs.

FACT: FDA requires generics to have the same quality, strength, purity, and stability as brand-name drugs.

MYTH: Generics are not as safe as brand-name drugs.

FACT: FDA requires that all drugs be safe and effective and that their benefits outweigh their risks. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts.

MYTH: Brand-name drugs are made in modern manufacturing facilities, and generics are often made in substandard facilities.

FACT: FDA won't permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year in all firms to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

MYTH: Generic drugs are likely to cause more side effects.
FACT: There is no evidence of this. FDA monitors reports of adverse drug reactions and has found no difference in the rates between generic and brand-name drugs.View Thread

Posted byPeskypain

20 Replies | ReplyReport This| Share this:Oxycodone vs. Oxycodone HCL- same thing? All from the FDA website on generics: Generics are not required to replicate the...

Reply: I think response F.D.A. to P.R.O.P.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnoucements/...

Absolutely....I am also all for medication that is made to deter abuse.

Posted by Peskypain

5 Replies | ReplyReport This| Share this:I think response F.D.A. to P.R.O.P. Absolutely....I am also all for medication that is made to deter abuse.

Reply: Oxycodone vs. Oxycodone HCL- same thing?

http://frontiernet.net

There are different Pharmaceutical laboratories that makes these medicines...there is...

Posted by Peskypain

20 Replies | ReplyReport This| Share this:Oxycodone vs. Oxycodone HCL- same thing? There are different Pharmaceutical laboratories that makes these medicines...there is...

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