Home > Terms > English, UK (UE) > Therapeutic equivalence (TE)
Therapeutic equivalence (TE)
Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria:
- they are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
- they are assigned by FDA the same therapeutic equivalence codes starting with the letter "A ." To receive a letter "A", FDA
- designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD).
- assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).
This is auto-generated content. You can help to improve it.
0
0
Improve it
- Part of Speech: noun
- Synonym(s):
- Blossary:
- Industry/Domain: Pharmaceutical
- Category: Drugs
- Company: U.S. FDA
- Product:
- Acronym-Abbreviation:
Other Languages:
Member comments
Terms in the News
Featured Terms
Industry/Domain: Internet Category: Virtual life
Virtual property inheritance
As maintaining an online life becomes more and more mainstream, people have a need to pass down their virtual belongings such as online identities, ...
Contributor
Featured blossaries
Marouane937
0
Terms
58
Blossaries
3
Followers
The 10 Worst African Economies
Category: Business 1 10 Terms
Browers Terms By Category
- Characters(952)
- Fighting games(83)
- Shmups(77)
- General gaming(72)
- MMO(70)
- Rhythm games(62)
Video games(1405) Terms
- Economics(2399)
- International economics(1257)
- International trade(355)
- Forex(77)
- Ecommerce(21)
- Economic standardization(2)
Economy(4111) Terms
- General astronomy(781)
- Astronaut(371)
- Planetary science(355)
- Moon(121)
- Comets(101)
- Mars(69)
Astronomy(1901) Terms
- Project management(431)
- Mergers & acquisitions(316)
- Human resources(287)
- Relocation(217)
- Marketing(207)
- Event planning(177)
Business services(2022) Terms
- Physical geography(2496)
- Geography(671)
- Cities & towns(554)
- Countries & Territories(515)
- Capitals(283)
- Human geography(103)