کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2495590 | 1116071 | 2010 | 14 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Bioanalytical method validation: An updated review
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موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
پزشکی مولکولی
پیش نمایش صفحه اول مقاله

چکیده انگلیسی
The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development, culminating in a marketing approval. The objective of this paper is to review the sample preparation of drug in biological matrix and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic (PK), toxicokinetic, bioavailability, and bioequivalence studies. Bioanalysis, employed for the quantitative determination of drugs and their metabolites in biological fluids, plays a significant role in the evaluation and interpretation of bioequivalence, PK, and toxicokinetic studies. Selective and sensitive analytical methods for quantitative evaluation of drugs and their metabolites are critical for the successful conduct of pre-clinical and/or biopharmaceutics and clinical pharmacology studies.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Pharmaceutical Methods - Volume 1, Issue 1, OctoberâDecember 2010, Pages 25-38
Journal: Pharmaceutical Methods - Volume 1, Issue 1, OctoberâDecember 2010, Pages 25-38
نویسندگان
Gaurav Tiwari, Ruchi Tiwari,