Bioequivalence and Bioavailability Forum

within subject standard deviation in fully replicate design if carry over effect is present [General Statistics]

posted by dshah – India, 2023-06-14 11:26 (708 d 09:44 ago) – Posting: # 23588
Views: 3,092

Hello Ankit!

❝ Cmax is due to the burst phase of release from the formulation however the plasma concentration required to produce therapeutic effect is very low i.e. < 5 % of Cmax and it remains in therapeutic range from Day 4 to 120 due to slow release of the product. It provides therapeutic effect for 4 months and then new injection has to be taken on day 120.

This seems to be LAI and from initial post also a HVD?

If by day 4- conc. are LT 5% of Cmax- then what is your half life? Why do you want to measure it for 120 days and the burst release doesn't have any toxicity impact? If even product name can not be shared- then it is difficult to be answered from very few details.

Regards,
Divyen

Complete thread:

within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-08 13:54 [General Statistics]
- within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-08 16:35
  - within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-09 07:15
    - within subject standard deviation in fully replicate design if carry over effect is presentdshah 2023-06-14 09:26
      - within subject standard deviation in fully replicate design if carry over effect is present Ankit Parikh 2023-06-14 09:33
        
        within subject standard deviation in fully replicate design if carry over effect is present dshah 2023-06-14 10:37

within subject standard deviation in fully replicate design if carry over effect is present [General Sta­tis­tics]

Complete thread:

within subject standard deviation in fully replicate design if carry over effect is present [General Statistics]