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1.
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Bioanalysis;
11(7): 645-653, 2019 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-30993999
2.
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Bioanalysis;
6(20): 2713-20, 2014 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25413703
3.
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).
Bioanalysis;
4(6): 651-60, 2012 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-22452256
4.
Comparative study on the bioequivalence of two formulations of pravastatin. Data from a crossover, randomised, open-label bioequivalence study in healthy volunteers.
Arzneimittelforschung;
56(2): 70-5, 2006.
Artículo
en Inglés
| MEDLINE | ID: mdl-16572920
5.
Comparative study on the bioequivalence of two different gabapentin formulations. A randomised, two-period, two-sequence, crossover clinical trial in healthy volunteers.
Arzneimittelforschung;
56(2): 59-63, 2006.
Artículo
en Inglés
| MEDLINE | ID: mdl-16572918
6.
Truncated AUC in the evaluation of fluconazole bioequivalence. A cross-over, randomised, open-label study in healthy volunteers.
Arzneimittelforschung;
54(11): 752-6, 2004.
Artículo
en Inglés
| MEDLINE | ID: mdl-15612616
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