Drugs Glossary Definition (English)
TE Defined
The following is in context to Drugs, because it's common for a single word to have multiple meanings you will find additional research links near the bottom of the page.
"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
o designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD).
o 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)."
, "The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). Sample TE codes: AA, AB, BC (More on TE Codes)
* FDA assigns therapeutic equivalence codes to pharmaceutical equivalent drug products. A drug product is deemed to be therapeutically equivalent ("A" rated) only if
o a drug company's approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug.
o those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected.
* Some drug products may have more than one TE Code. (More about multiple TE Codes)
* Those products which the FDA does not deem to be therapeutically equivalent are "B" rated. (More on TE Codes)"
Additional Languages
Additional TE Definition Starting Points
The following links are listed in alphabetical order. Please note we cannot guarantee TE definitions are contextually accurate to Drugs at third party websites.
