# \[e-drug\] RFI: Bioequivalence and generics registration (3)

**URL:** https://talk.edrugplus.org/t/e-drug-rfi-bioequivalence-and-generics-registration-3/19760
**Category:** e-drug
**Created:** [June 4, 2004, 7:27am UTC](https://talk.edrugplus.org/t/e-drug-rfi-bioequivalence-and-generics-registration-3/19760 "2004-06-04T07:27:46Z")
**Posts on this page:** 1
**Page:** 1

<div class="post-metadata">

### Author: ![Milind\_Nadgouda](https://avatars.discourse-cdn.com/v4/letter/m/9dc877/32.png) [@Milind\_Nadgouda](https://talk.edrugplus.org/u/Milind_Nadgouda)
#### Post date: [June 4, 2004, 7:27am UTC](https://talk.edrugplus.org/t/e-drug-rfi-bioequivalence-and-generics-registration-3/19760/1 "2004-06-04T07:27:46Z")

</div>

E-DRUG: RFI: Bioequivalence and generics registration (3)  
---------------------------------------------------------

Hi there Mr Anonymous;

I am a Regulatory Affairs specialist in a private  
company and have worked on the regulated, semi  
regulated and the non regulated markets for  
registration of generic version of pharmaceutical  
products.

When ever you say that you are establishing  
Bio-equivalence between the Innovator Brand and the  
New Generic, you have to carry out a bio-study. The  
parameters that would be assessed are T1/2 (biological  
half life), Cmax & Tmax. Now when we have these three  
minimum criteria to be established to deem  
bio-equivalency between two products. Secondly you  
also have to know that a plain dissolution (in vitro)  
profile will not suffice, it has to be a proper IVIVC  
(Invitro Invivo corelation) calcutated using the f1 &  
f2 values.

Now your question should a developing country ask for  
these parameters...well dont we think that by laxing a  
few procedures in testing you are inviting a lot of  
unruly generics who would not necessarily have good  
therapeutic effect but however qualify on a  
physico-chemical parameter assessment and get  
registered. Even small countries or developing  
coutries do request a complete Bio study and it is not  
difficult for new entrants to give it mainly because  
they will have already carried out a bio for atleast  
one market and will have it ready...so inclusion of  
this in the larger interest of GOOD QUALITY MEDICATION  
to the public should be the outlook. Especially if you  
are in a policy making & decision making  
authoratative position it would really be better if  
you give it a good thought than think about how a  
developing nation is going to afford this.

Regards,

Milind Nadgouda  
Cadila Pharmaceuticals Limited  
India  
milindnadgouda@yahoo.co.uk

--  
To send a message to E-Drug, write to: e-drug@healthnet.org  
To subscribe or unsubscribe, write to: majordomo@healthnet.org  
in the body of the message type: subscribe e-drug OR unsubscribe e-drug  
To contact a person, send a message to: e-drug-help@healthnet.org  
Information and archives: [http://www.essentialdrugs.org/edrug](http://www.essentialdrugs.org/edrug)