pharm07
☆    

India,
2021-06-22 11:09
(167 d 05:29 ago)

Posting: # 22425
Views: 758
 

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

How to fit pk parameters derived from IV lower strength data with ER/IR/MR/DR higher strength oral formulation data? What are the pk parameters needs to focus?

Regards,
pharm07
drgunasakaran1
★★  
avatar

2021-06-24 06:07
(165 d 10:31 ago)

@ pharm07
Posting: # 22430
Views: 596
 

 IV Infusion/Bolus Pk normalisation

Dear Mr Pharm07,

» How to fit pk parameters derived from IV lower strength data with ER/IR/MR/DR higher strength oral formulation data? What are the pk parameters needs to focus?

Could you please elaborate more on the query to provide appropriate answer?

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
msmnainar
★    

India,
2021-06-24 07:11
(165 d 09:27 ago)

@ pharm07
Posting: # 22431
Views: 587
 

 IV Infusion/Bolus Pk normalisation

» How to fit pk parameters derived from IV lower strength data with ER/IR/MR/DR higher strength oral formulation data? What are the pk parameters needs to focus?

Hi

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.

However, I dont understand the selection of IV lower strength and oral higher strength. Do you have any correlation on data?

Sundar. M
pharm07
☆    

India,
2021-06-24 07:48
(165 d 08:50 ago)

@ msmnainar
Posting: # 22432
Views: 575
 

 IV Infusion/Bolus Pk normalisation

» 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.
»
» 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]

Regards,
pharm07
msmnainar
★    

India,
2021-06-24 19:04
(164 d 21:34 ago)

@ pharm07
Posting: # 22433
Views: 554
 

 IV Infusion/Bolus Pk normalisation

Hi,

Per my previous reply, you can validate through the difference in bioavailability between your P.O and iv formulation.

IV would be considered as 100% BA, hence based on the difference you can normalize the data.

Sundar. M
pharm07
☆    

India,
2021-06-25 04:51
(164 d 11:47 ago)

@ msmnainar
Posting: # 22434
Views: 537
 

 IV Infusion/Bolus Pk normalisation

Thank you.. :-)


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]

Regards,
pharm07
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