jag009
★★★

NJ,
2020-03-12 15:41

Posting: # 21259
Views: 2,774
 

 Comp in-vitro disso studies for generics in India [Dissolution / BCS / IVIVC]

Hi everyone,

I have question relating to ANDA in India (CDSCO). With US ANDA, we have the FDA recommended dissolution method for a marketed drug which the generic company needs to carry out the Test vs Ref in-vitro with (if the method is not doable for some reason then the company must justify they have to use another meothod). Does this exist in India? If not then, what's the approach for India ANDA (I mean aside from developing your own method for your product and compare against the ref).

Reference article link, if available, would be greatly appreciated.

Thx
J
ping4santosh
☆    

India,
2020-03-12 19:18

@ jag009
Posting: # 21260
Views: 986
 

 Comp in-vitro disso studies for generics in India

Hi jag009,

AFAIK, it's upto the company to develop the disso profile and submit the data with acceptable range of F values.

If I have time over weekend, I will try to find references.

Cheers,
SKM
jag009
★★★

NJ,
2020-03-13 17:34

@ ping4santosh
Posting: # 21268
Views: 932
 

 Comp in-vitro disso studies for generics in India

Thank you ping4santosh. Lastly, is there a requirment on what kind of testings need to be done on the reference product (i.e, potenty or total assay, any others)? I know the US rules but not if it's the same as in India.

Thanks
J
ping4santosh
☆    

India,
2020-03-14 23:20
(edited by ping4santosh on 2020-03-14 23:49)

@ jag009
Posting: # 21270
Views: 877
 

 Comp in-vitro disso studies for generics in India

Hello Jag,

I know the US rules but not if it's the same as in India...

Please let us know the US rules.

Lastly, is there a requirment on what kind of testings...

You need to show the disso profile in different medias with different pH mimicking the various zones of bio absorption. It again depends on the BCS classification of the product and the use of solublizers. It will be helpful if you post your understanding of US rules so that I would know where to guide you.

Cheers,
SKM
jag009
★★★

NJ,
2020-03-15 07:25

@ ping4santosh
Posting: # 21271
Views: 858
 

 Comp in-vitro disso studies for generics in India

Hi,

» I know the US rules but not if it's the same as in India...
»
» Please let us know the US rules.

In terms of disso, for US you have to follow the FDA recommended dissolution method listed for the designated reference product. If there is no FDA method then you use the USP method.


Thx
J
ping4santosh
☆    

India,
2020-03-15 10:05

@ jag009
Posting: # 21276
Views: 859
 

 Comp in-vitro disso studies for generics in India

Hi J,

» In terms of disso, for US you have to follow the FDA recommended dissolution method listed for the designated reference product. If there is no FDA method then you use the USP method.

Selection of a disso method, the way you perform in industries depend on many factors - -

As you say If its USA, it should meet USP; japan - JP; india - IP etc..... If you want to sell in a country, prove that your product meets their pharmacopoeial limits

Whether an established method for dissolution testing of Drug or its product is available in pharmacopoeia or not? If yes, go on as per their procedure

If no, go for any other good pharmacopoeial test already set for a particular product.
else You can go for your own in-house methods...

Also there will be some other reasons why certain industries do in-house tests specifically. Even in that case, they show that their product meets the limits.

Hope it helps!
Cheers,
SKM


Edit: Standard quotes restored; see also this post #8. [Ohlbe]
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