Regulatory Open Forum

Dear Regex,
When is it more appropriate to use model-dependent  methods in comparative dissolution profile study rather than f2 method? In this case, how to select the best model-dependent method suitable for the product (From Weibull, Higuchi, Peppas,...etc)? 
Also, form your experience, is it easily accepted by regulatory authorities to use model-dependent methods instead of f2?
Thank you all in advance.

------------------------------
Alaa El Kazak Msc. RAC
Jeddah
Saudi Arabia
------------------------------

@Rachel Thornton any advice please?

---------------------------------
Alaa El Kazak


Jeddah
Saudi Arabia
---------------------------------



Original Message:
Sent: 09-Oct-2020
From: Alaa El Kazak
Subject: Comparative dissolution profile model dependent vs. independent

Dear Regex,
When is it more appropriate to use model-dependent  methods in comparative dissolution profile study rather than f2 method? In this case, how to select the best model-dependent method suitable for the product (From Weibull, Higuchi, Peppas,...etc)? 
Also, form your experience, is it easily accepted by regulatory authorities to use model-dependent methods instead of f2?
Thank you all in advance.

------------------------------
Alaa El Kazak Msc. RAC
Jeddah
Saudi Arabia
------------------------------

All my experience is in biologics (vaccines and mAbs/Fabs), so I'm afraid I can't really comment. Sorry.

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 09-Oct-2020 10:16
From: Alaa El Kazak
Subject: Comparative dissolution profile model dependent vs. independent

@Rachel Thornton any advice please?

---------------------------------
Alaa El Kazak


Jeddah
Saudi Arabia

Original Message:
Sent: 09-Oct-2020
From: Alaa El Kazak
Subject: Comparative dissolution profile model dependent vs. independent

Dear Regex,
When is it more appropriate to use model-dependent  methods in comparative dissolution profile study rather than f2 method? In this case, how to select the best model-dependent method suitable for the product (From Weibull, Higuchi, Peppas,...etc)?
Also, form your experience, is it easily accepted by regulatory authorities to use model-dependent methods instead of f2?
Thank you all in advance.

------------------------------
Alaa El Kazak Msc. RAC
Jeddah
Saudi Arabia
------------------------------

Thanks alot.

---------------------------------
Alaa El Kazak


Jeddah
Saudi Arabia
---------------------------------



Original Message:
Sent: 09-Oct-2020
From: Rachel Thornton
Subject: RE: Comparative dissolution profile model dependent vs. independent

All my experience is in biologics (vaccines and mAbs/Fabs), so I'm afraid I can't really comment. Sorry.

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 09-Oct-2020 10:16
From: Alaa El Kazak
Subject: Comparative dissolution profile model dependent vs. independent

@Rachel Thornton any advice please?

---------------------------------
Alaa El Kazak


Jeddah
Saudi Arabia

Original Message:
Sent: 09-Oct-2020
From: Alaa El Kazak
Subject: Comparative dissolution profile model dependent vs. independent

Dear Regex,
When is it more appropriate to use model-dependent  methods in comparative dissolution profile study rather than f2 method? In this case, how to select the best model-dependent method suitable for the product (From Weibull, Higuchi, Peppas,...etc)?
Also, form your experience, is it easily accepted by regulatory authorities to use model-dependent methods instead of f2?
Thank you all in advance.

------------------------------
Alaa El Kazak Msc. RAC
Jeddah
Saudi Arabia
------------------------------