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dpksangwan ☆ India, 2012-12-05 18:58 (4954 d 16:30 ago) Posting: # 9675 Views: 5,494 |
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Can anyone help me to know whether we can conduct babe study on everolimus 0.75 mg on healthy volunteers in india. it would be really helpful if someone could also provide me the reference of studies conducted on healthy volunteers on same strength. Edit 1: message title edited to use lower-case. Why are you SCREAMING ? Please see the Forum etiquette [Ohlbe] Edit 2: username changed from all-capitals for the same reasons. [Helmut] |
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Dr_Dan ★★ Germany, 2012-12-06 17:35 (4953 d 17:53 ago) @ dpksangwan Posting: # 9684 Views: 4,737 |
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Dear dpksangwan Maybe this helps: W. Cheung, C. Ligia, A. Jappe, O. Anak: Pharmacokinetic (PK) profile of a single dose of everolimus (10 mg) administered with a low- or high-fat meal and under fasting conditions in healthy subjects. J Clin Oncol 29: 2011 (suppl; abstr e15080) J. A. Palma, M. Pereda, M. Lopez, T. Castro Sr., O. Hernandez, C. Trujillo, E. Nunez: Pharmacokinetics of a single 2-mg dose of everolimus in healthy Mexican volunteers. J Clin Oncol 28, 2010 (suppl; abstr e13157) J. M. Kovarik, D. Beyer, M. N. Bizot, Q. Jiang, M. Shenouda, R. L. Schmouder: Blood Concentrations of Everolimus Are Markedly Increased by Ketoconazole. J Clin Pharmacol May 2005 vol. 45 no. 5 514-518 J. M. Kovarik, D. Beyer, M. N. Bizot, Q. Jiang, M. J. Allison, R. L. Schmouder: Pharmacokinetic interaction between verapamil and everolimus in healthy subjects. Br J Clin Pharmacol. 2005 October; 60(4): 434-437. J. M. Kovarik, S. Hartmann, J. Figueiredo, C. Rordorf, G. Golor, A. Lison, K. Budde, H. H. Neumayer: Effect of Food on Everolimus Absorption: Quantification in Healthy Subjects and a Confirmatory Screening in Patients with Renal Transplants. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy Volume 22, Issue 2, pages 154-159, February 2002 Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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dpksangwan ☆ India, 2012-12-24 09:29 (4936 d 01:59 ago) (edited on 2012-12-24 13:56) @ Dr_Dan Posting: # 9753 Views: 4,166 |
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drgunasakaran1 ★★  2012-12-08 12:26 (4951 d 23:02 ago) @ dpksangwan Posting: # 9696 Views: 6,180 |
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❝ Can anyone help me to know whether we can conduct babe study on everolimus 0.75 mg on healthy volunteers in india. Dear Mr dpksangwan, Yes. You can conduct BA/BE study in healthy volunteers with Everolimus 0.75 mg tablets. Everolimus Tablets (0.25 mg/0.5 mg/0.75 mg/1.0 mg) were approved for Immunosuppresant Indication by CDSCO on 30-08-2004. But, if you plan to conduct BA/BE study with Everolimus 10 mg strength, then you need to have study population as "Patients who are already receiving the Everolimus at a dose of 10 mg once a day as their individual therapy". Everolimus 5/10mg Tablets were approved by CDSCO for the treatment of advance renal cell carcinoma on 16.05.2009. You need to get BENOC from Indian Drug Regulatory before conducting BE study with Everolimus 10 mg strength. ❝ it would be really helpful if someone could also provide me the reference of studies conducted on healthy volunteers on same strength Reference: FDA's Access data on Zortress (everolimus) Tablets, 0.25 mg, 0.5 mg, and 0.75 mg of Novartis Pharmaceuticals Corp. Application No.: 021560, Clinical Pharmacology and Biopharmaceutics Review, NDA Application no:21-560s000 — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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dpksangwan ☆ India, 2012-12-24 09:28 (4936 d 01:59 ago) (edited on 2012-12-24 13:55) @ drgunasakaran1 Posting: # 9752 Views: 4,157 |
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Thank you very much sir. But referring to DCGI approval list we conducted BE study on efavirenz and erlotinib later the regulatory raised questions regarding data on healthy volunteers. Regards, Deepak Sangwan 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! [Ohlbe] |
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