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M.Vasu ★ India, 2011-02-10 15:14 (5202 d 12:09 ago) Posting: # 6612 Views: 8,573 |
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Hi All, Plz let me know if C of A is required for a method development trial study (1 way using reference product only). If possible kindly suggest with proper guideline. Thanks in Advance!!!!!!! VM Edit: Category changed. [Helmut] |
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Ohlbe ★★★ France, 2011-02-10 17:01 (5202 d 10:22 ago) @ M.Vasu Posting: # 6613 Views: 7,547 |
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Dear VM, CoA of what: - of the investigational medicinal product administered to the subjects ? I would say yes. You want to be sure of what you give the subject. Not as important as in a BE (where you want to know the difference between T and R), but there is still an ethical concern. - of the reference material you use in the lab to spike the standards and QCs ? This can be discussed more. On the one hand this is just a development study, so not regulated by guidelines. On the other hand you need some guarantee on whatever material you are going to use (You don't really care whether it is 99.9 or 99.8 % pure, but if it is just 80 %...). The answer depends on the source of the product and on the final goal of the study (what information do you want to get when giving only the reference product ?). Regards Ohlbe — Regards Ohlbe |
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M.Vasu ★ India, 2011-02-10 17:18 (5202 d 10:05 ago) @ Ohlbe Posting: # 6614 Views: 7,587 |
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Dear Ohlbe, i) CoA of the investigational medicinal product (Reference product) which is administered to the subjects only. However, protocol was approved by ethics commitee. Plz let me know the ethical concerns. ii) Final goal of the study is to develop a method. Regards VM |
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Ohlbe ★★★ France, 2011-02-10 23:31 (5202 d 03:52 ago) @ M.Vasu Posting: # 6616 Views: 7,606 |
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Dear VM, ❝ Plz let me know the ethical concerns. Giving subjects a drug which has not been analysed or properly identified is of concern. Regards Ohlbe — Regards Ohlbe |
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Dr_Dan ★★ Germany, 2011-02-16 12:00 (5196 d 15:23 ago) @ Ohlbe Posting: # 6634 Views: 7,429 |
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Dear Ohlbe ❝ Giving subjects a drug which has not been analysed or properly identified is of concern. I guess the (reference) drug was purchased from the local market, right? So the originator analysed the product (batch) in order to release it. Every physician prescribing this product has to rely on this procedural step and by this on the quality. Since this is a registrated and marketed product I can see no ethical concern as long as the product is not manipulated before administration. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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M.Vasu ★ India, 2011-02-17 05:24 (5195 d 21:59 ago) @ Dr_Dan Posting: # 6638 Views: 7,433 |
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Hi Dr_Dan, I do agree, this is a registrated and marketed product (reference). As per the IEC approved protocol it was stated that the study will conduct in complince with the GCP. However, i feel as per GCP sec 8.2.16 (C of A of IP's shipped) sponsor has to file C of A. Regards, VM |
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Dr_Dan ★★ Germany, 2011-02-17 11:26 (5195 d 15:57 ago) @ M.Vasu Posting: # 6640 Views: 7,434 |
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Dear VM usually you perform a clinical study in order to make a statement about the efficacy, the safety, the bioavailability etc. of the tested product. For this you definitely need to know the quality of the product. In your case you just need plasma samples in order to develop a bioanalytical method and there is no gain in knowledge about the drug. That's why I think that a CoA is not of that importance. Nevertheless it is always better to proof the assay content of the drug and if you use the data to describe the pharmacokinetics of the reference product in order to plan a BE study it would be better to have a CoA. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Ohlbe ★★★ France, 2011-02-21 20:09 (5191 d 07:14 ago) @ Dr_Dan Posting: # 6655 Views: 7,372 |
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Dear Dan, If the drug was sampled from the local market, there is indeed no real problem. I'm more concerned about a product sampled from a foreign market. Think how the BfArM would react if you intended to run a study in Germany with a non-EU product, without a release by a QP. But it may actually be a regulatory issue as much as an ethical question. Regards Ohlbe — Regards Ohlbe |
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Dr_Dan ★★ Germany, 2011-02-22 10:42 (5190 d 16:41 ago) @ Ohlbe Posting: # 6657 Views: 7,382 |
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Dear Ohlbe You are right, you can not run a study in Germany with a non-EU product, without a release by a QP etc. You need a CTA, IMPD and so on. But as far as I understand we are not talking about a clinical study. The investigator treats the volunteers with a registered drug in order to get plasma samples. You can not call this clinical use but it is also no clinical study, something in between. IMHO if you want to do it correctly you have to submit a CTA including IMPD and I guess nobody would spent such effort and costs (I know it is done illegally without any protocol or ethics vote, just administer the drug to one or two volunteers, draw some blood samples and nobody cares). Regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz