Ritonavir Bioequivalence [Design Issues]

posted by Mahesh M – India, 2014-06-12 16:15 (4392 d 03:42 ago) – Posting: # 13063
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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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