| Document Date: 2006-11-13 08:05:24
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Company GlaxoSmithKline / Glaxosmithkline plc / / Event FDA Phase / Product Issues / / IndustryTerm metabolic systems / prevention of PONV as well as cancer / / MedicalCondition Postoperative-Induced Nausea / loss of consciousness / vomiting occurring / sudden blindness / pediatric cancer / convulsions / bronchospasm / cancer / post-operative nausea / postoperative induced nausea / amaurosis / patient reported nodal arrhythmia / chemotherapy-induced nausea / patient experiences nausea / nausea / chemotherapy-induced nausea/vomiting / pain / Chemotherapy Induced Nausea / vomiting / staphylococcal infection / tachycardia / respiratory depression / diarrhea / Post-operative Induced Nausea / post-operative nausea/vomiting / transient second-degree heart block / profound hypotension / hypotension / dehydration / / MedicalTreatment chemotherapy / surgery / / Organization FDA / / Person Lolita Lopez / Ruyi He / Lolita A. Lopez / / Position investigator / EXECUTIVE / Medical Officer / Medical Team Leader / M.D. Medical Team Leader / / Product granisetron / phenytoin / Zofran / Zofran ODT / carbamazepine / Ondansetron Hydrochloride / ondansetron / Zofran ODT® / S3A40319 / CYP3A4 / CYP1A2 / fertility / / Technology pharmacokinetics / chemotherapy / /
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http://www.fda.gov/cder/foi/esum/2005/20007s035_ZOFRAN_CLINICAL_BPCA.pdf