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kumar ☆ 2009-04-25 15:14 (6275 d 13:23 ago) Posting: # 3611 Views: 6,947 |
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I am working on a simple old molecule that used to be a common household remedy for common ailments and was no more than an OTC drug for more than 80 years. Lot of literature is available for that old indication. Not used much now for that particular indication because of the availability of newer and better molecules. But now it has found a new indication at a lower / or same dose orally and can be used in extreme emergency / life threatening toxicity conditions only for 10-14 days and is not of the category of daily use. I am working for that new indication and intend to market it in EU. There is a scarcity of clinical trial data on its safety and efficacy for new indication as it is difficult to carry out the clinical trials as the emergency / toxicity conditions for which it is used do not happen daily and it is difficult to simulate such conditions as well. Most of the information available is because of its past use in such circumstances by coincidence. I would like to know is it necessary to conduct the BE for this drug with new indication? How can I demonstrate its BA / Bio- Equivalence to the reference product already marketed in EU and USA? Can some learned members help me in this case? Regards Kumar -- Edit: Subject line changed. Helmut |
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ElMaestro ★★★ Denmark, 2009-04-25 16:32 (6275 d 12:05 ago) @ kumar Posting: # 3612 Views: 6,014 |
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Hi Kumar, I am not sure I can follow you so well here: is there a product authorised in the EU which has this new emergency indication? If this is the case then 1. a straightforward BE study should do it, provided the drug is not locally acting or some other obscure phenomenon. 2. there will be an SPC somewhere where you can learn some basic things about the drug, which may be helpful for the design of the trial intended to evaluate BE. Best regards EM. |
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kumar ☆ 2009-04-25 16:58 (6275 d 11:39 ago) @ ElMaestro Posting: # 3613 Views: 6,046 |
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Dear EM, Thank you for the mail. This product is already authorised in EU & USA as an innovator. The drug is not locally acting. We have seen the SPC and is not of much help. As a generic product, we need to demonstrate its BE with the innovator. We do not have much bibliographic reference to ask for a waiver? We do not know in what way we can conduct clinical trials and BE Studies. Need help. Regards Kumar -- 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! Helmut |
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Helmut ★★★   Vienna, Austria, 2009-04-25 17:34 (6275 d 11:03 ago) @ kumar Posting: # 3614 Views: 6,273 |
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Dear Kumar, when answering messages, please delete anything from the text of the original message which is not necessary in understanding your answer; see also this post and the Forum's Policy. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kumar ☆ 2009-04-27 09:52 (6273 d 18:44 ago) @ Helmut Posting: # 3616 Views: 5,961 |
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Dear Helmut, My apologies and thanks for reminding me. However, I felt that the original text message should not appear by default when we click the reply button !!!! Trust you concur. Regards Kumar |
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Helmut ★★★ Vienna, Austria, 2009-04-27 15:46 (6273 d 12:50 ago) @ kumar Posting: # 3621 Views: 6,123 |
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Dear Kumar! ❝ [...] I felt that the original text message should not appear by default when we click the reply button !!!! Trust you concur. The administrative team of the forum had a discussion two weeks ago about your suggestion. We edited 8.3% of posts in the last year to remove 'Full quotes'. Our decision was:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kumar ☆ 2009-04-27 17:18 (6273 d 11:19 ago) @ Helmut Posting: # 3622 Views: 5,938 |
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Dear Helmut, Thank you for the mail. I have arguments both in favour and against. I feel that once a person reads a messsage and then feels strongly to reply to that and clicks on the "reply" button, his mind is still fresh with the original message and is working inside the mind what to reply !!!!! However, in case of a lengthy message, when one has to reply formally point wise, then one needs to refer back to the original message. I feel that very few people read the terms and conditions fully in such sites including the sites like yahoo. msn or gmail when one signs for the first time; unless and until there is some indication of a "price / cost" factor. Trust you concur. I admit, I was one of those people. My best regards, Kumar |
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Helmut ★★★ Vienna, Austria, 2009-04-27 18:00 (6273 d 10:37 ago) @ kumar Posting: # 3623 Views: 6,018 |
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Dear Kumar! ❝ I feel that once a person reads a messsage and then feels strongly to reply to that and clicks on the "reply" button, his mind is still fresh with the original message and is working inside the mind what to reply !!!!! ![[image]](img/uploaded/image7.gif) sss !!!!! Are you suffering from blocked keys?  I believe that your mind may be fresh, but any forum lives from the public exchange of opinions (that’s where the word comes from). It’s cumbersome for other readers to follow a chain of arguments if they are not visible. Only in ‘Mix view’-mode of the forum the previous post is displayed in the same webpage. Although this mode is the Forum’s default, users may set the ‘Thread view’ in their profile as well. In such a case only the subject line of the original post is displayed. ❝ However, in case of a lengthy message, when one has to reply formally point wise, then one needs to refer back to the original message. Agree. ❝ I feel that very few people read the terms and conditions fully in such sites including the sites like yahoo. msn or gmail when one signs for the first time; unless and until there is some indication of a "price / cost" factor. Fine. During the registration procedure a message is displayed in bold: By the registration I confirm that I have read and accepted the Policy of the Forum. I’m running this site at my costs; so please accept my rules. Furthermore all people answering questions do so in their leisure time.If you want to discuss this topic further, please open a new thread in the Forum Internals category. This category is open for registered users only and is not displayed in public. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kumar ☆ 2009-04-27 09:58 (6273 d 18:39 ago) @ Helmut Posting: # 3617 Views: 5,972 |
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Dear Helmut I just noticed that you changed the subject line of my mail; and it was too late to be edited by me !!!! The drug in question was an OTC for earlier indication. But for the new indication it has to be taken on the advise of the Physician only. Regards, Kumar |
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Helmut ★★★ Vienna, Austria, 2009-04-27 13:55 (6273 d 14:42 ago) @ kumar Posting: # 3620 Views: 6,107 |
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Dear Kumar! ❝ I just noticed that you changed the subject line of my mail; and it was too late to be edited by me !!!! OK, but you could have changed the subject lines of your later posts if you felt the one I have chosen not to be adequate. I considered the one you originally gave (‘BE Studies’) rather uninformative. To quote the Forum's Policy: Give a short description of your question in the subject line; try to be as specific as possible (something like ‘HELP!!!’ or ‘BE statistics?’ is just not a good idea). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2009-04-26 00:43 (6275 d 03:54 ago) @ kumar Posting: # 3615 Views: 6,056 |
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Hi Kumar, ❝ We have seen the SPC and is not of much help. OK, but I think in the absence of a drug name and some more info from your side your chances are slim that someone here is able to help you design the right trial. As for bibliographical/biowaiver I think this will not work. If I get you right, the new indication is... well... new, which suggests it does not have "well-established use". So, I think it would be a good idea that you describe the drug better here and hope somebody knows the details you need, or you conduct a pilot in order to get at least some basic idea about the PK characteristics incl. intra- and inter-subject variability. EM. |
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kumar ☆ 2009-04-27 10:14 (6273 d 18:23 ago) @ ElMaestro Posting: # 3618 Views: 5,959 |
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Dear EM, Thank you for the reply. I am afraid I can not disclose the name of the drug as I am bound by a non-disclosure agreement with the sponsor. As I told earlier, the drug is an old molecule. Hence, PK data is available in healthy individuals at "that" dose which is little higher than the "new dose". But for the new indication, the clinical data is scarce. We have only 3 live reports of emergency conditions worldwide wherein this drug was used effectively by the Governments. And in one of the situations, a follow-up study was done post dosing to assess its side effects. Best regards, Kumar |
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ElMaestro ★★★ Denmark, 2009-04-27 20:44 (6273 d 07:53 ago) @ kumar Posting: # 3624 Views: 5,956 |
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Dear Kumar, ❝ I am afraid I can not disclose the name of the drug (...) Well, in the absence of a drug name and some information it is a little difficult to suggest anything. ❝ But for the new indication, the clinical data is scarce. We have only 3 live reports of emergency conditions worldwide wherein this drug was used effectively by the Governments. Wow, silly me, I thought drugs were used by the medical profession. This drug is used by 'Governments'. Say no more, hush hush, or 'they' will come and get you.  Efficacy proven in three subjects? "4.1: Governocin is indicated for males aged 46-53 who choke on a pretzel while on board a Belgian schooner south of Equator". I bet the marketing people in the originator company do not have an easy job selling it.  You know what Kumar? You need a consultant, to whom you can disclose a bit more info, after which it will be much easier for you to receive useful feedback. I recommend you to contact Bebac (http://bebac.at). The owner is a competent fellow, so I've heard. Best regards, EM. |
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Helmut ★★★ Vienna, Austria, 2009-04-27 22:34 (6273 d 06:03 ago) @ ElMaestro Posting: # 3625 Views: 6,005 |
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¡ ElMaestro ! ❝ "4.1: Governocin is indicated for males aged 46-53 who choke on a pretzel while on board a Belgian schooner south of Equator". Belgian schooner? Are you sure Governocin {  } is not indicated on Dutch schooners only? I’ve heard about Belgian master brewers & chocolate-makers, but the Belgian seamanship, well…  ❝ I recommend you to contact Bebac (http://bebac.at). The owner is a competent fellow, so I've heard. You’ve gotta be kidding! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2009-04-28 21:35 (6272 d 07:01 ago) @ Helmut Posting: # 3629 Views: 6,042 |
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¡ El consultor competente ! ❝ Belgian schooner? Are you sure Governocin { I assure you there is nothing wrong with Belgian beer or with Belgian seamanship and there is absolutely nothing negative to say about the combination of the two. EM. |
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Helmut ★★★ Vienna, Austria, 2009-04-28 21:43 (6272 d 06:54 ago) @ ElMaestro Posting: # 3630 Views: 5,920 |
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¡ ElMaestro ! ❝ I assure you there is nothing wrong with Belgian beer Yes, I know! I like your proficiency in finding relevant facts in the net! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kumar ☆ 2009-04-28 10:28 (6272 d 18:08 ago) @ ElMaestro Posting: # 3626 Views: 5,915 |
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Dear EM, Thank you for the mail and the advise....like it and could say a lot! But I think we have skidded off the track. With this limited information, can you or somebody suggest me if the BE is really necessary for this product or how can I ask for a waiver? Regards Kumar |
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Ohlbe ★★★ France, 2009-04-28 13:34 (6272 d 15:03 ago) @ kumar Posting: # 3627 Views: 5,974 |
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Dear Kumar, A BE trial will never give you a therapeutic indication that the reference product does not have. If you want to get a new indication:
One suggestion if you decide to start a real development anyway: ask for orphan drug status. Regards Ohlbe |
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kumar ☆ 2009-04-29 14:42 (6271 d 13:54 ago) @ Ohlbe Posting: # 3634 Views: 5,874 |
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Dear Ohlbe, Thank you for the advise. Clinical trials in patients are difficult as such "accidental" conditions do not happen on daily basis and this drug is used prophylactically to prevent further damage, toxicity and death. As regards the Orphan drug status, I am not sure because I thought this status is granted to drugs used in diseases affecting no more than 5 in 10000 people. And our drug will be used by masses or the whole population, if required. Regards Kumar |
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Ohlbe ★★★ France, 2009-04-29 15:53 (6271 d 12:44 ago) @ kumar Posting: # 3635 Views: 5,776 |
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Dear Kumar, ❝ Clinical trials in patients are difficult as such "accidental" conditions do not happen on daily basis and this drug is used prophylactically to prevent further damage, toxicity and death. ❝ And our drug will be used by masses or the whole population, if required. You will never get an indication for primary prevention of whatever disease with an administration possibly to the whole population, just based on the description of 3 cases in the literature ! When statins requested an indication for primary prevention of myocard infarction in patients with high cholesterol, they had to run trials in thousands (or even tens of thousands) of patients, to get enough events. Unless of course you are dealing with a disease which is not supposed to happen naturally at all... But then you need to discuss with the Ministry of Defense, not of Health  Regards Ohlbe |
Ing. Helmut Schütz