Biomarker method validation in anticancer drug development
نویسندگان
چکیده
منابع مشابه
Fit-for-purpose biomarker method validation in anticancer drug development.
The introduction of new anticancer drugs into the clinic is often hampered by a lack of qualified biomarkers. Method validation is indispensable to successful biomarker qualification and is also a regulatory requirement. Recently, the fit-for-purpose approach has been developed to promote flexible yet rigorous biomarker method validation, although its full implications are often overlooked. Thi...
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متن کاملRP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms
A new, rapid, economical and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of eptifibatide acetate, a small synthetic antiplatelet peptide, in bulk drug substance and pharmaceutical dosage forms. The developed method was validated as per of ICH guidelines. The chromatographic separation was achieved isocratically on C18 colum...
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ژورنال
عنوان ژورنال: British Journal of Pharmacology
سال: 2008
ISSN: 0007-1188
DOI: 10.1038/sj.bjp.0707441