Bioequivalence and Bioavailability Forum • Biosimilars

Biosimilars [Design Issues]

posted by Kumarnaidu2 – India, 2021-10-22 09:53 (1696 d 02:13 ago) – Posting: # 22653
Views: 5,271

Dear All,

For a medicinal product to be administer as intravenous infusion (for approx. 3 hrs) if we consider Ctrough as one of the primary pk parameter for demonstrating PK similarity, does different rate of infusion amongst enrolled subjects has any impact on Ctrough levels?

Thanks in advance,

Kumar

Complete thread:

Biosimilars M.Vasu 2011-11-24 14:01
- Biosimilars Helmut 2011-11-24 14:44
  - Biosimilars M.Vasu 2011-11-28 12:33
    - Healthy subjects vs. patients Helmut 2011-11-28 12:56
    - Biosimilars drgunasakaran1 2012-02-06 13:57
  - Biosimilars Ben 2011-12-16 19:04
- Biosimilars Chiku 2012-02-03 06:43
  - Biosimilars drgunasakaran1 2012-02-10 11:33
    - Biosimilars Chiku 2012-02-10 12:03
      - BiosimilarsKumarnaidu2 2021-10-22 07:53