Bioequivalence and Bioavailability Forum • DCGI

bharat narnavar
☆

India,
2014-01-23 12:08
(4537 d 06:09 ago)

Posting: # 12239
Views: 6,240

DCGI [Regulatives / Guidelines]

Dear All
I have following questions

Bioequivalence study for Anticancer drugs is suggested on healthy volunteers as per USFDA Recommendation and various regulatory so we are applying for BENOC application for export purpose with study design on healthy volunteers but from your kind office we have received the letter for either do the study on patients or it is recommended for the NDAC so, we need clarification regarding same can we proceed for BENOC application with study design for every anticancer drug on the patients instead of the healthy volunteers.
Eg:
1. Bexarotene
2. Erlotinib Hydrochloride
3. Abiraterone Acetate
what about the antipsychotic drugs, for antipsychotic drugs also we have to apply with patients only or it will be case to case basis.
On which basis DCGI office decided the category of the drugs whether drug below to category of new drug, approved less than 1 year, approved between1 to 4 year or old drug, because the list given on the website is not enough to chose the category to which drug belong?
The given list on website for some of the drugs only name is given without any information of the strength and dosage form.
Eg: In Year 1999 only drug names mentioned without information of dosage form and strength.
The notification or amendment if any is it necessary to take the approval from DCGI office or acknowledgement copy received from your office is sufficient to commence the study.
Typographical error occurs from DCGI office on BENOC, query letter etc is it necessary to notify you the same?
Typographical error occurs from applicant side is it necessary to notify DCGI?

Thanks in advance
Regards
Bharat Narnavar

Dr_Dan ★★ Germany, 2014-01-23 15:43 (4537 d 02:34 ago) @ bharat narnavar Posting: # 12242 Views: 4,324	DCGI Post reply
	Dear Bharat Narnavar Your post looks rather like a letter to the DCGI office than a post to forum members ("your office"). Nethertheless we would be very interested how DCGI replies to your questions. Kind regards Dan — Kind regards and have a nice day Dr_Dan

bharat narnavar ☆ India, 2014-01-24 08:45 (4536 d 09:32 ago) (edited on 2014-01-24 11:59) @ Dr_Dan Posting: # 12254 Views: 4,236	DCGI Post reply
	Dear dan Please give the answer if you have experience for above points Yes this is all for DCGI Office Thanks in advance Regards Bharat 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! [Dr_Dan]

Dr_Dan ★★ Germany, 2014-01-24 13:01 (4536 d 05:16 ago) @ bharat narnavar Posting: # 12258 Views: 4,120	DCGI Post reply
	Dear Bharat Unfortunately I have too little experience with DCGI to give advice. I suggest to contact DCGI office directly. Kind regards Dan — Kind regards and have a nice day Dr_Dan

bharat narnavar ☆ India, 2014-01-24 13:12 (4536 d 05:05 ago) @ Dr_Dan Posting: # 12259 Views: 4,124	DCGI Post reply
	Dear Dan i will do it. Thanks Bharat 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! [Helmut]

pravin17
★

India,
2014-01-25 13:25
(4535 d 04:51 ago)

@ bharat narnavar
Posting: # 12268
Views: 4,183

DCGI

Post reply

❝ 1. Bioequivalence study for Anticancer drugs

❝ 2. what about the antipsychotic drugs

I dont have experiance for above two points

❝ 3. On which basis DCGI office decided the category of the drugs ... The given list on website for some of the drugs only name is given without any information of the strength and dosage form.

Ans: you will get this information from Indian Pharmacopoeia of respective year

❝ 4. The notification or amendment if any is it necessary to take the approval from DCGI office ...

Yes, Changes should be notified to DCGI.

❝ 5. Typographical error occurs from DCGI office on BENOC, query letter etc is it necessary to notify you the same?

Yes it should be notified you will get the corrected from DCGI

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! [Helmut]