Bioequivalence and Bioavailability Forum • Therapeutic Equivalence

Therapeutic Equivalence [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2011-10-20 22:14 (5366 d 14:15 ago) – Posting: # 7528
Views: 7,669

Hi yanliu,

❝ TE, PE or BE are the type of equivalence studies.

Wearing European goggles I see it differently.
I understand PE as just similarity in terms of brutto composition. BE on the other hand needs qualification by studies. These may be dissolution, PK or PD depending on the specific application and which side of the pond you are situated; BE has a slightly different meaning in US compared to EU.

While we are at it:
How do you experts out there distinguish essential similarity from TE in Europe? And what about ES vs TE vs BE in the US? Is TE truly when two products display same efficacy and safety but not necessarily same availability (rate and extent) at the site of action or whut?

Somebody hit me with a hammer, please.

Complete thread:

Therapeutic Equivalence maulik963 2011-10-19 11:45
- Therapeutic Equivalence Helmut 2011-10-19 11:57
  - Therapeutic Equivalence ElMaestro 2011-10-19 22:38
    - Therapeutic Equivalence Helmut 2011-10-20 00:28
      - Therapeutic Equivalence maulik963 2011-10-20 10:45
        
        Therapeutic Equivalence yanliu622 2011-10-20 19:16
        
        Therapeutic EquivalenceElMaestro 2011-10-20 20:14
        
        Therapeutic Equivalence JMCardot 2011-10-24 12:18
        
        Therapeutic Equivalence ElMaestro 2011-10-24 13:51
        
        Therapeutic Equivalence JMCardot 2011-10-24 21:16
        Going Off-Topic Helmut 2011-10-24 22:15