Anand
☆    

India,
2015-03-11 12:38
(3305 d 18:44 ago)

Posting: # 14559
Views: 13,494
 

 Bio-waiver for Pregabalin Capsules [Dissolution / BCS / IVIVC]

Dear All,

We are developing Pregabalin Capsules,

We are going to file BCS based Bio-waiver approach by below data,

Drug Solubility:
  1. API Solubility(pH 1.2 to 7.2).
  2. Dissolution(API + Finished Product)
  3. Composition & Process similarity
Permeability:
  1. We are going to file Literature support for Pregabalin high Permeable (Class I) whether USFDA will accept our ANDA or not?
Regards,
A.Anand
Bio-PK


Edit: Category changed. [Helmut]
Tina
★    

India,
2015-03-11 18:27
(3305 d 12:56 ago)

@ Anand
Posting: # 14560
Views: 11,563
 

 Bio-waiver for Pregabalin Capsules

Dear Anand,

FDA's guidance on pregabalin (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm162465.pdf) clearly states the following for BCS biowaiver route:

It may be possible to request a waiver of in-vivo testing for all the strengths of this product provided that the appropriate documentation regarding high solubility, high permeability and rapid dissolution as detailed in the Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence for Immediate – Release Solid Oral Dosage Forms Based on the Biopharmaceutics Classification System is submitted in the application. You may use information contained in the approved labeling of the reference product. Peer reviewed articles may not contain the necessary details of the testing for the Agency to make a judgment regarding the quality of the studies. A decision regarding the acceptability of the waiver request can only be made upon review of the data submitted in the application.

Essentially if data submitted satisfies the FDA requirement, it could be fine.

Kind regards,
Tina
Samaya B
☆    

India,
2015-03-12 14:15
(3304 d 17:08 ago)

@ Tina
Posting: # 14561
Views: 11,454
 

 Bio-waiver for Pregabalin Capsules

Dear Anand,

In my opinion, Literature reference for permeability in terms of caco 2 cell permeability values should be acceptable to FDA.

If this value is not directly available, you can define high permeability using absolute bioavailability, rapid and complete absorption after oral administartion, mass balance data / % of unchanged drug recovered, wide therapeutic window for said drug.

Hope this would be helpful.

Regards,
Samaya.
luvblooms
★★  

India,
2015-03-13 10:18
(3303 d 21:05 ago)

@ Samaya B
Posting: # 14563
Views: 11,394
 

 Bio-waiver for Pregabalin Capsules

Dear Samaya

❝ In my opinion, Literature reference for permeability in terms of caco 2 cell permeability values should be acceptable to FDA.

❝ If this value is not directly available, you can define high permeability using absolute bioavailability, rapid and complete absorption after oral administartion, mass balance data / % of unchanged drug recovered, wide therapeutic window for said drug.


In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that.
Also if the product/molecule is highly variable, FDA will ask you to do a BE study.

But in general for Pregabalin, these shall not be the concern!!

Hope this will help.

~A happy Soul~
Maitri
☆    

India,
2017-11-16 12:41
(2324 d 18:41 ago)

@ luvblooms
Posting: # 17984
Views: 6,055
 

 Bio-waiver for Pregabalin Capsules

❝ In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that.


Dear luvblooms,

Can you just mentioned the few probable reasons for not accepting the published literature information? If the Clinical Pharmacology and biopharmaceutics data of Innovator clearly demonstrated a validated permeability study conducted using all the standards (low permeable, moderate permeable, high permeable, zero permeable) will it be acceptable in your opinion? :confused:

Thank You in advance! :-)
Maitri


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]
Dr_Dan
★★  

Germany,
2015-03-12 14:49
(3304 d 16:33 ago)

@ Anand
Posting: # 14562
Views: 11,382
 

 Bio-waiver for Pregabalin Capsules

Dear Anand
The absolute bioavailability in humans is estimated to be more than 90%. (see EPAR Lyrica)
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
109 visitors (0 registered, 109 guests [including 4 identified bots]).
Forum time: 07:23 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5