B - Product example

3rd

!

A generic medicine is a medicine that is an equivalent substitute to a brand name drug. Generic medicines contain the same active ingredients as the original brand products, and are available in the same strengths and dosage forms as the originals. A generic drug must work the same way in your body and produce the same treatment result as the brand name drug 01.

All brand-name drugs have a generic name. The generic name often appears next to the brand name and is the active ingredient(s) in the medication. Regulators often require that generic drugs are given a different name than the brand-name drugs, in order to avoid confusion. Typically, the generic name of a medicine is based on the name of its active ingredient(s), whereas the names given to brand-name drugs are intended for marketing purposes. There are a few unique cases where the generic medicine may also have another name besides the active ingredient. Ask your pharmacist if you have any questions.

A generic drug is bioequivalent to the brand-name innovative drug and meets the same quality standards. The active ingredient, the content, the dosage form and the usage of a generic drug are similar to those of an innovative drug. Regulatory authorities review the safety of both brand and generic prescription drugs before they are approved for use in a country. They also continue to monitor safety of these medications after approval 02.

Bioequivalence demonstrates a similar profile of behavior of two products in the human body, in terms of the rate and extent of absorption of the active pharmaceutical ingredient from the gastrointestinal (GI) tract to the blood stream. Bioequivalence study is a regulatory requirement and is performed for all generic drugs to ensure their efficiency and safety.