Latest 15 posts. http://forum.bebac.at/ Bioequivalence and Bioavailability Forum en helmut.schuetz@bebac.at (Helmut Schütz) http://forum.bebac.at/img/bebac-small.png Bioequivalence and Bioavailability Forum http://forum.bebac.at/ 7550 AB anova in BE http://forum.bebac.at/mix_entry.php?id=8054 Post by AB, 2012-02-05 15:21:

Hi,
can anyone say what is the ANOVA used in the 2x2 corssover bioequivalance study? is it a two way anova?
regards,
AB]]> http://forum.bebac.at/forum_entry.php?id=8054 Sun, 05 Feb 2012 15:21:31 +0100 HS Between subject differences in Xovers http://forum.bebac.at/mix_entry.php?id=8053 Reply from HS, 2012-02-04 11:30:

Dear Vardhan!

» […] While compiling the data for making report for TGA, we came to know that some of the subjects were out of BMI range that is 17.65 to 31.43kg/m² (18.5 to 30 kg/m² as per TGA), But BMI criteria was not captured in the protocol.
»
» Whether TGA will accepts this data as the BMI is out of the range. But study is meeting the criteria.
I don’t think this should be a major problem. No guideline exists concerning proportionality studies. TGA’s BE GL states:

The inclusion/exclusion criteria should be clearly stated in the protocol. Subjects should be 18 years of age or older and preferably have a Body Mass Index between 18.5 and 30 kg/m².

(my emphases)
You have stated inclusion criteria in the protocol. The body height / mass range wasn’t the preferred one – but so what? Extreme values should not bother you in a cross-over design. Simply mention it in the report.]]> http://forum.bebac.at/forum_entry.php?id=8053 Sat, 04 Feb 2012 11:30:52 +0100 JMCardot Dissolution of Effervescent Tablets http://forum.bebac.at/mix_entry.php?id=8052 Reply from JMCardot, 2012-02-04 10:58:

Dear Joyjac,

Dissolution for effervescent tablets (usually soluble compounds are inside effervescent tablets) is quite a nonsence as you are forming your solution in the glass before you drink it (with some minor exceptions). Of course you have some requirements in the EP and USP for those tablets -less than 5 minutes for complete dissolution in a "glass"- if I remember but check for that.

Best regards,

JM]]> http://forum.bebac.at/forum_entry.php?id=8052 Sat, 04 Feb 2012 10:58:52 +0100 drgunasakaran1 Bioequivalence criteria for endogenous drug http://forum.bebac.at/mix_entry.php?id=8051 Reply from drgunasakaran1, 2012-02-04 05:31:

Dear Mr.Pash413,

The primary Pharmacokinetic parameters need to estimated for Endogenous substances are Cmax, AUC0-t and AUC0-inf. Bioequivalence criteria need to evaluated for Cmax, AUC0-t and AUC0-inf. FDA will not usually accept, if you submit AUC0-inf data only as supportive evidence excluding from Bioequivalence criteria.]]> http://forum.bebac.at/forum_entry.php?id=8051 Sat, 04 Feb 2012 05:31:51 +0100 drgunasakaran1 DCGI BE-NOC http://forum.bebac.at/mix_entry.php?id=8050 Reply from drgunasakaran1, 2012-02-03 13:19:

Dear Mr.Rave,

If the drugs are approved in the 2007 and the drug is available in the Indian market for more than 04 years, then there is no need for BE NOC. However, you may need to apply for T License if your are planning to import the investigational product from foreign countries in case if your are planing to conduct the above two studies for USFDA/EMEA/other foreign regulatory bodies.

» Rest two are Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC & Levonorgestrel 0.75 mg but we are manufacturing them for more than 4 years. please help!!!
Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC was approved by CDSCO on 13.10.10.
Ref: http://cdsco.nic.in/LIST%20OF%20APPROVED%20DRUG%20FROM%2001.htm


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post --> 550! [Helmut]]]> http://forum.bebac.at/forum_entry.php?id=8050 Fri, 03 Feb 2012 13:19:16 +0100 pash413 Bioequivalence criteria for endogenous drug http://forum.bebac.at/mix_entry.php?id=8049 Post by pash413, 2012-02-03 12:15:

Deal All

For USFDA submission biostudies,is it essential to prove bioequivalence for AUC 0-inf for endogenous drug. Does FDA accepts bioequivalence criteria based on only Cmax and AUC0-t result. As no clarity is given either in USFDA general guidance or in the individual BE guidance for endogenous drug,what should be our approach. As sometime it is not possible to reliably estimate the elimination phase from baseline corrected data, is it OK if we write in our protocol in the prior that the BE will be based on only Cmax and AUC0-t data and the AUC0-inf data shall be submitted as supportive/information purpose.

Kindly advise.]]> http://forum.bebac.at/forum_entry.php?id=8049 Fri, 03 Feb 2012 12:15:23 +0100 auditor Change in ULOQ concentration http://forum.bebac.at/mix_entry.php?id=8048 Post by auditor, 2012-02-03 08:28:

Dear All,

In one of the validation it is observed that the ULOQ is decrees from 3000 pg/ml to 500 pg/ml. To justify this only one P&A is injected. I feel to justify this recovery and DI need to be perform again as QC level is also change accordingly.

Kindly give you suggestion on this.

Regards,

Auditor]]> http://forum.bebac.at/forum_entry.php?id=8048 Fri, 03 Feb 2012 08:28:57 +0100 rave04 DCGI BE-NOC http://forum.bebac.at/mix_entry.php?id=8047 Reply from rave04, 2012-02-03 07:31:

Thank you Mr.Vardhan for your help.


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post --> 550! [Helmut]]]> http://forum.bebac.at/forum_entry.php?id=8047 Fri, 03 Feb 2012 07:31:09 +0100 rave04 DCGI BE-NOC http://forum.bebac.at/mix_entry.php?id=8046 Reply from rave04, 2012-02-03 07:23:

Thank you very much Mr.Gunasakarn
We are applying for four formulation out of which I got approval date for 2 but remaining two is not available. Two which are approved are in year 2007. So how to go about them for BE-NOC. Rest two are Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC & Levonorgestrel 0.75 mg but we are manufacturing them for more than 4 years. please help!!!

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post --> 550! [Ohlbe]]]> http://forum.bebac.at/forum_entry.php?id=8046 Fri, 03 Feb 2012 07:23:21 +0100 Vardhan82 DCGI BE-NOC http://forum.bebac.at/mix_entry.php?id=8045 Reply from Vardhan82, 2012-02-03 06:57:

Dear Rave04,

» I am applying to DCG India to get BE-NOC for products which we are selling for more than 4 years but still our two products are not found in the approved list of the DCGI. please help as we are going to conduct BE study in India.
 Approval details have been available only from 1999 in CDSCo site, which is not covering complete FDC list. if your formulation is IR, you can conduct the study without NOC as you may have form 46 for the same.

Regards,

vardhan]]> http://forum.bebac.at/forum_entry.php?id=8045 Fri, 03 Feb 2012 06:57:48 +0100 drgunasakaran1 DCGI BE-NOC http://forum.bebac.at/mix_entry.php?id=8044 Reply from drgunasakaran1, 2012-02-03 06:45:

Dear Mr.Rave,

Did you checked the DCGI approval status of the products in their online Approval checking page
http://cdsco.nic.in/listofdrugapprovedmain.html

DCGI updated the drugs which are approved for marketing in India from the year 1999 only.

If the drugs are approved for marketing in India before 1999, it will not be available in the website. You can send an Email to DCGI for a PDF document which contains the CDSCO approved drugs from the year Jan 1988 - Jun 1999.

I hope that the two products you are mentioning here is not a Fixed Dose Combination. If it is a FDC, the criteria to apply for BENOC will vary.]]> http://forum.bebac.at/forum_entry.php?id=8044 Fri, 03 Feb 2012 06:45:17 +0100 Chiku Biosimilars http://forum.bebac.at/mix_entry.php?id=8043 Reply from Chiku, 2012-02-03 06:43:

Hi Vasu,

As far as FDA is concerned i am not able to find specific guideline for biosimiler. But from my very little experience i can say: u will require to have
1) Sameness
a) Bilogical sameness---PK/PD study either in Human or Animal model case by case basis
b) analytical sameness by Size exclusion, Elisa etc suitable method for structure elucidation depends on molecule charecteristics

2) Bioequivalence with PK end point

3) Immunogenesity if applicable


Regards

Chiku:)]]> http://forum.bebac.at/forum_entry.php?id=8043 Fri, 03 Feb 2012 06:43:53 +0100 Vardhan82 BMI vs LIC for age and weight chart http://forum.bebac.at/mix_entry.php?id=8042 Post by Vardhan82, 2012-02-03 06:26:

Dear All,

We have conducted Dose proportionality study for ANVISA submission, study was comfortably meeting the criteria. Hence, decided to submit same study to TGA by making the report in TGA format as well additional documentation required for TGA. The subjects were enrolled as per LIC for age and weight chart as the study planned for ANVISA. While compiling the data for making report for TGA, we came to know that some of the subjects were out of BMI range that is 17.65 to 31.43kg/m² (18.5 to 30 kg/m² as per TGA), But BMI criteria was not captured in the protocol.

Whether TGA will accepts this data as the BMI is out of the range. But study is meeting the criteria.

Thanks in advance for your help.

Thanks,

Vardhan]]> http://forum.bebac.at/forum_entry.php?id=8042 Fri, 03 Feb 2012 06:26:43 +0100 rave04 DCGI BE-NOC http://forum.bebac.at/mix_entry.php?id=8041 Post by rave04, 2012-02-03 06:10:

Hi frnds,
I need little help from u all
I am applying to DCG India to get BE-NOC for products which we are selling for more than 4 years but still our two products are not found in the approved list of the DCGI. please help as we are going to conduct BE study in India.]]> http://forum.bebac.at/forum_entry.php?id=8041 Fri, 03 Feb 2012 06:10:15 +0100 Ohlbe Statistical Out come http://forum.bebac.at/mix_entry.php?id=8040 Reply from Ohlbe, 2012-02-02 19:13:

Dear Auditor,

Is this a fed study ? Prazoles sometimes have a very strange behaviour in these studies (you'll find some discussions if you search the forum).

Regards
Ohlbe]]> http://forum.bebac.at/forum_entry.php?id=8040 Thu, 02 Feb 2012 19:13:11 +0100