Bioequivalence and Bioavailability Forum • IV Infusion/Bolus Pk normalisation

IV Infusion/Bolus Pk normalisation [Dissolution / BCS / IVIVC]

posted by pharm07 – India, 2021-06-24 07:48 (123 d 02:17 ago) – Posting: # 22432
Views: 490

» Usually AUC is the parameter you can compare, if you are looking to generate absolute bioavailability details. However, your dose selection depends upon the bioavailability of extravascular administration.
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» However, I dont understand the selection of IV lower strength and oral higher strength. Do you have any correlation on data?

Hi, Thanks for your inputs.

To be very specific, if i need to validate the predicted p.o. profile from IV Infusion which is a lower dose than oral, then how to scaleup pk parameter to validate oral predictive profile?

For eg, I have IV infusion 10 mg and i wanted to validate the 80mg oral.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

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Regards,
pharm07

Complete thread:

IV Infusion/Bolus Pk normalisation pharm07 2021-06-22 11:09 [Dissolution / BCS / IVIVC]
- IV Infusion/Bolus Pk normalisation drgunasakaran1 2021-06-24 06:07
- IV Infusion/Bolus Pk normalisation msmnainar 2021-06-24 07:11
  - IV Infusion/Bolus Pk normalisationpharm07 2021-06-24 07:48
    - IV Infusion/Bolus Pk normalisation msmnainar 2021-06-24 19:04
      - IV Infusion/Bolus Pk normalisation pharm07 2021-06-25 04:51