Achievwin
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US,
2024-06-07 17:42
(10 d 23:47 ago)

Posting: # 24024
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 simulating dissolution data beyond observed lab data [Dissolution / BCS / IVIVC]

Can anyone point out me towards a step by step process for modeling and simulating dissolution data for prolonged duration (0-90 days) based on the lab data for a defined period (0-10 days)?

Can we use R for this exercise (any examples?)
Helmut
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Vienna, Austria,
2024-06-07 18:30
(10 d 22:59 ago)

@ Achievwin
Posting: # 24025
Views: 425
 

 simulating dissolution data beyond observed lab data

Hi Achievwin,

❝ Can anyone point out me towards a step by step process for modeling and simulating dissolution data for prolonged duration (0-90 days) based on the lab data for a defined period (0-10 days)?

If your cumulative dissolution is visually flattening, yes. Otherwise, you are fishing in the dark. Can you post some data?

❝ Can we use R for this exercise [?]

Likely. It depends on the number of parameters of the function you will fit (e.g., monoexponential, Weibull…) and sampling time points you have. In any case, the confidence interval of the prediction beyond the observed data may become terribly wide, rendering this exercise a game of chance.

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dshah
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India/United Kingdom,
2024-06-10 11:10
(8 d 06:19 ago)

@ Achievwin
Posting: # 24027
Views: 297
 

 simulating dissolution data beyond observed lab data

Hi Achievwin,

I agree with Helmut's input.
Further- the assumptions used for extrapolation of modeling, the function/model used used for extrapolation, limitation of used model can be considered on a brief.
Generally, dissolution condition which can fasten the rate of release can be tried for e.g. increasing temperature, rpm, change over media, etc. so that it can be confirmed that the drug release is complete.

Regards,
Divyen
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