| Generic Drugs |
| A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. |
| BIOEQUIVALENT STUDIES |
| The most common way to 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 the rate and extent of absorption or bioavailability of the generic drug, which can then be compared to that of the pioneer drug. |
| REQUIREMENTS FOR APPROVAL |
- Contain the same active ingredients as the innovator drug (inactive ingredients may vary)
- Be identical in strength, dosage form, and route of administration
- Have the same use indications
- Be bioequivalent
- Meet the same batch requirements for identity, strength, purity, and quality
- Be manufactured under the same strict standards of FDA�s GMP regulations required for innovator products
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| RBP OFFERS FOLLOWING PRODUCTS AND SERVICES |
- Auditing GMP and GCP facilities
- Developing protocols for bioequivalence studies
- Selecting clinical trial sites
- Recruiting patients/volunteers with informed consent
- Monitoring clinical trials and managing clinical data
- Meeting and corresponding with regulatory authorities
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