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rajasekharkakarla ☆ India, 2018-10-06 10:05 (2372 d 09:45 ago) Posting: # 19411 Views: 5,991 |
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Dear All, I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts: 1) Can I use remaining quantity of reference drug for pivotal 2) If we use remaining IPs, Is we need to get Test license permission for pivotal. or Is we need to apply fresh Test license to import Reference drug separately for pivotal. Please guide me to overcome this issue. Regards, RK |
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Obinoscopy ★ USA, 2018-10-06 14:58 (2372 d 04:52 ago) @ rajasekharkakarla Posting: # 19412 Views: 4,720 |
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Dear Rajasekharkakarla, It depends on which NRA you intend seeking MAH from. If from outside India or if seeking PQP from WHO, then it doesn't matter as long as the reference product is on their list of approved comparator products/RLDs. But if from India, then it depends on their guideline. What was the content of the Test License given you? Was it stated anywhere on that letter that the reference product being imported is for pilot studies only? What was the correspondence etween you and the India NRA? did you tell them that the reference product is intended for Pilot Studies only? These are the things you have to consider. Regards, — Scopy |
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wienui ★ Germany/Oman, 2018-10-07 23:04 (2370 d 20:46 ago) @ rajasekharkakarla Posting: # 19414 Views: 4,695 |
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Dear RK, ❝ I applied Test license for some X drug in India, I got permission and I imported the drug (reference) from outside India then conducted one study (pilot). Now I want to conduct one more study (pivotal) with remaining quantity of Reference drug from first study. Here I have some doubts: ❝ 1) Can I use remaining quantity of reference drug for pivotal ❝ 2) If we use remaining IPs, Is we need to get Test license permission for pivotal. Yes, you will need. Regards, Osama — Cheers, Osama |
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qualityassurance ★ 2023-09-28 14:29 (554 d 05:21 ago) @ wienui Posting: # 23726 Views: 3,090 |
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Dear Mr. Osama, ❝ No, You can't use the rest of the reference drug for conducting a BE Study with a new ordered reference drug batch, as they are two different Batches (Biobatches). What if sponsor sent 1 bottle containing 56 tabs. of RLD to CRO for pilot study from which only 12 tabs. were utilized. Can rest of the tablets be used for pivotal study from the same opened bottle of RLD? Of course storage conditions were maintained in pharmacy of CRO. Regards, QA |
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wienui ★ Germany/Oman, 2023-09-28 20:12 (553 d 23:38 ago) @ qualityassurance Posting: # 23727 Views: 3,146 |
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❝ What if sponsor sent 1 bottle containing 56 tabs. of RLD to CRO for pilot study from which only 12 tabs. were utilized. Can rest of the tablets be used for pivotal study from the same opened bottle of RLD? Of course storage conditions were maintained in pharmacy of CRO. Dear QA, Sure in this case you can use the rest of the tablets (same batch Nr.) as long as the expiration date is still valid. — Cheers, Osama |
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dshah ★★ India, 2023-10-03 19:27 (549 d 00:23 ago) @ qualityassurance Posting: # 23735 Views: 3,025 |
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Dear QA and RK! ❝ ❝ What if sponsor sent 1 bottle containing 56 tabs. of RLD to CRO for pilot study from which only 12 tabs. were utilized. Can rest of the tablets be used for pivotal study from the same opened bottle of RLD? Of course storage conditions were maintained in pharmacy of CRO. ❝ - Does the remaining quantity is sufficient for testing or will you have sufficient retention samples? Generally the RLD samples are directly shipped to CRO and thus sponsor's may not have sufficient quantity of retention samples. Regards, Divyen Shah |
Ing. Helmut Schütz