Huifen Faye Wang

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CP-724,714, a potent and selective orally active HER2 tyrosine kinase inhibitor, was discontinued from clinical development due to unexpected hepatotoxicity in cancer patients. Based on the clinical manifestation of the toxicity, CP-724,714 likely exerted its hepatotoxicity via both hepatocellular injury and hepatobiliary cholestatic mechanisms. The direct(More)
Most therapeutic monoclonal antibodies are designed to bind a specific antigen to elicit pharmacological effects. Accurate quantification of a therapeutic monoclonal antibody in biological matrices is essential for assessing its pharmacokinetics and selecting an effective dosing regimen. Therapeutic antibodies may exist in free, partially bound and fully(More)
Abbreviations: AE: Adverse Event; AUC: Area under Plasma Concentration–time Curve; AUCinf: Area under Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time; AUClast: Area under Plasma Concentration–time Curve from Time Zero to the Time of the Last Quantifiable Concentration; BMI: Body Mass Index; CI: Confidence Interval; Cmax: Maximum(More)
A survey of the rabbit's normal microcirculation of blood flow volume in the endometrium and myometrium with or without a copper intrauterine device (IUD) was made. It was found through statistical analyses that the IUD stimulated the endometrium so that microcirculation of blood flow volume in the endometrium increased significantly, but it did not change(More)
BACKGROUND Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB). SETTING This study was conducted at a single centre--the Pfizer Clinical Research Unit in Singapore. (More)
BACKGROUND RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis. SETTING This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore. OBJECTIVE To demonstrate bioequivalence of each drug component between RIN-150 and(More)
Registration of innovative biologics in Emerging Markets (EMs) poses many opportunities and challenges. The BRIC-MT countries (Brazil, Russia, India, China, Mexico, and Turkey) that are the fastest growing markets and regulators in these countries have imposed certain requirements, including the need for local clinical studies, for registration of(More)