CLINICAL PHARMACOKINETICCLINICAL PHARMACOKINETIC

GLP

GLP NOTE

FREQUENTLY ASKED QUESTION ABOUT GENERIC DRUGS

Frequently Asked Questions about Generic Drugs

1. What are generic drugs?
2. Are generic drugs as safe as brand-name drugs?
3. Are generic drugs as strong as brand-name drugs?
4. Do generic drugs take longer to work in the body?
5. Why are generic drugs less expensive?
6. Are brand-name drugs made in more modern facilities than generic drugs?
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
8. Does every brand-name drug have a generic counterpart?
9. What is the best source of information about generic drugs?

1. What are generic drugs?

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

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2. Are generic drugs as safe as brand-name drugs?

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

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3. Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

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4. Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

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5. Why are generic drugs less expensive?

Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

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6. Are brand-name drugs made in more modern facilities than generic drugs?

No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to 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.

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7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

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8. Does every brand-name drug have a generic counterpart?

No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

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9. What is the best source of information about generic drugs?

Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.

DEFINATION

Defination for QA

Indian pharmacopiea and British Pharmacopoiea

Indian & British Pharmacopiea:download link

Hello Frnds,

Here is the links for IP and BP……

http://www.esnips.com/doc/66b36a4f-9154-48a8-abba-d9b252ed1eb6/Monographs-from-Indian-Pharmacopoeia-1996
(Indianpharmacopiea)

http://rapidshare.com/users/JLOZQT
(Cd-Rom of Britishpharmacopiea)

method validation

method validation

Different volumes of water recommended

Different volumes (between 100 ml and ~240 ml) are recommended in national guidelines. An overwiew is given below: European Union 150 ml water http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf

 Australia (EU Guideline adopted) 150 ml water http://www.tga.gov.au/docs/pdf/euguide/ewp/140198entga.pdf

Canada 150 ml water http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-a_e.pdf http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/bio-b_e.pdf

 WHO 150 ml fluid http://www.who.int/medicines/library/qsm/manual-on-marketing/who-dmp-rgs-985.doc

Japan 100–200 ml water (normally 150 ml) http://www.nihs.go.jp/drug/be-guide(e)/Generic/be97E.pdf

Malaysia at least 150 ml fluid http://www.bpfk.gov.my/pdfworddownload/MSIA%20BEguide_part1.pdf

Brazil 200 ml liquid (generally water) http://www.anvisa.gov.br/hotsite/genericos/legis/resolucoes/478_02re_e.htm South Africa 200 ml fluid http://www.mccza.com/documents/2.06%20Biostudies%20Dec%2003%20v1.zip USA 8 ounces (237 ml) water http://www.fda.gov/cder/guidance/5356fnl.pdf http://www.fda.gov/cder/guidance/5194fnl.pdf

Mexico 250 ml water http://www.farmacopea.org.mx/legisla/legal28.asp

 New Zealand standardized (no volume stated) http://www.medsafe.govt.nz/downloads/vol1.doc

bio equivaence guidance

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