Bioequivalence and Bioavailability Forum • Sequence Effect on Endogenous Drugs

Sequence Effect on Endogenous Drugs [Regulatives / Guidelines]

posted by Lucas – Brazil, 2014-02-11 18:45 (4517 d 14:10 ago) – Posting: # 12406
Views: 10,530

Hello Helmut!

❝ Good questions. Next question. ;-)

❝ I have some mixed feelings when it comes to endogenous compounds. You never know which effects you might induce in the body. In all (‼) cross-over studies on biosimilars I have seen there were significant sequence effects… Have a look at the total CVs of your studies. Maybe you can consider running a parallel study?

The inter-subject CV was 24~25%, so a parallel study may be a practical solution. I'll suggest that. Thanks.

Complete thread:

Sequence Effect on Endogenous Drugs Lucas 2014-02-10 20:01
- Sequence Effect on Endogenous Drugs ElMaestro 2014-02-10 20:09
  - Sequence Effect on Endogenous Drugs Lucas 2014-02-11 12:24
    - Sequence Effect on Endogenous Drugs ElMaestro 2014-02-11 13:26
      - Sequence Effect on Endogenous Drugs Lucas 2014-02-11 17:38
- Sequence Effect on Endogenous Drugs jag009 2014-02-10 21:35
  - Sequence Effect on Endogenous Drugs Lucas 2014-02-11 12:28
    - Sequence Effect on Endogenous Drugs jag009 2014-02-11 17:21
      - Sequence Effect on Endogenous Drugs Lucas 2014-02-11 17:33
- Sequence Effect on Endogenous Drugs Helmut 2014-02-11 15:07
  - Curious jag009 2014-02-11 17:16
  - Sequence Effect on Endogenous DrugsLucas 2014-02-11 17:45
- Four studies with the same formulation Lucas 2014-02-11 17:32
  - Four studies with the same formulation jag009 2014-02-11 20:01