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hnasri ☆ 2014-06-06 19:01 (4400 d 17:59 ago) Posting: # 13040 Views: 4,883 |
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Hi everybody! Could anyone tell me if it is possible to explore a biowaiver for Ritonavir 100 mg softgel capsules? If not what would be the design to establish bioequivalence? Regards! Edit: Category changed. [Helmut] |
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hnasri ☆ 2014-06-11 22:24 (4395 d 14:36 ago) @ hnasri Posting: # 13060 Views: 3,833 |
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Dear all! Would somebody take a stab at this and give a idea what would be the design to establish bioequivalence for ritonavir 100mg softgels? Regards! Edit: Relax and read the Forum’s Policy in the meantime. [Helmut] |
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Mahesh M ★ India, 2014-06-12 16:15 (4394 d 20:45 ago) @ hnasri Posting: # 13063 Views: 3,854 |
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Dear Hnasri, ❝ Would somebody take a stab at this and give a idea what would be the design to establish bioequivalence for ritonavir 100mg softgels? Two way crossover design is suggested by USFDA.kindly find the below link for your references http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm089595.pdf http://apps.who.int/prequal/whopar/whoparproducts/HA467Part6v1.pdf http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_BioPharmr.pdf http://www.medadvocates.org/resources/conferences/international_aids_conferences/17/lopinavir_index/17N.pdf Hope it will healp you. Regards |
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hnasri ☆ 2014-06-18 01:02 (4389 d 11:58 ago) @ Mahesh M Posting: # 13078 Views: 3,732 |
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Dear Mahesh! Thank you for your response! Hassen |
Ing. Helmut Schütz