دورية أكاديمية
Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
| العنوان: | Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. |
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| المؤلفون: | Smolec J; Alta Analytical Laboratory, San Diego, California, USA. josmolec@alta-immunochem.com, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, Khan M, Tacey R, Hill H, Celniker A, Shah V, Bowsher R, Mire-Sluis A, Findlay JW, Saltarelli M, Quarmby V, Lansky D, Dillard R, Ullmann M, Keller S, Karnes HT |
| المصدر: | Pharmaceutical research [Pharm Res] 2005 Sep; Vol. 22 (9), pp. 1425-31. Date of Electronic Publication: 2005 Aug 24. |
| نوع المنشور: | Journal Article; Review; Validation Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Print ISSN: 0724-8741 (Print) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 1999- : New York, NY : Kluwer Academic/Plenum Publishers Original Publication: Stuttgart ; New York : Thieme, c1984- |
| مواضيع طبية MeSH: | Chemistry Techniques, Analytical* , Pharmacokinetics*, Calibration ; Reference Standards ; Reproducibility of Results ; Sensitivity and Specificity |
| مستخلص: | The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants. |
| Number of References: | 5 |
| References: | Pharm Res. 2001 Sep;18(9):1373-83. (PMID: 11683255) Pharm Res. 2003 Nov;20(11):1885-900. (PMID: 14661937) |
| تواريخ الأحداث: | Date Created: 20050901 Date Completed: 20060104 Latest Revision: 20191210 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1007/s11095-005-5917-9 |
| PMID: | 16132353 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 0724-8741 |
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| DOI: | 10.1007/s11095-005-5917-9 |