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1 .
The Effect of Food on the Single‐Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine
저자
by
Marinela Chirila
;
Simona Rizea-Savu
;
Simona Nicoleta Duna
;
Adriana Iordachescu
;
Adrian Ghita
.
소스
Clinical Pharmacology in Drug Development
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7 .
The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
저자
by
Andrea Wakefield
;
Barry van der Strate
;
Elizabeth Groeber
;
Saadya Fatmi
;
Jing Tu
, et al.
소스
Bioanalysis
. 9:505-516
Open Access (OpenAIRE)
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7 .
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
저자
by
Xinping Fang
;
Cheikh Kane
;
Valentine Barra
;
Dawn Dufield
;
Marsha Luna
, et al.
소스
Bioanalysis
. 11(18s)
Open Access (OpenAIRE)
Scopus
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7 .
11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation
저자
by
Franklin Spriggs
;
Chris Beaver
;
Ashley Brant
;
Daniel Sikkema
;
Susan Ohorodnik
, et al.
소스
Bioanalysis
. 10(7)
Open Access (OpenAIRE)
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7 .
Development and validation of an HPLC–MS/MS method to quantify clopidogrel acyl glucuronide, clopidogrel acid metabolite, and clopidogrel in plasma samples avoiding analyte back-conversion
저자
by
Luigi Silvestro
;
Isabela Tarcomnicu
;
Adriana Iordachescu
;
Simona Rizea Savu
;
Ariana Tudoroniu
, et al.
소스
Analytical and Bioanalytical Chemistry
. 401:1023-1034
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7 .
Development and validation of an HPLC-MS/MS method to determine clopidogrel in human plasma. Use of incurred samples to test back-conversion
저자
by
Mihaela Gheorghe
;
Isabela Tarcomnicu
;
Simona Rizea Savu
;
Constanta Dulea
;
Silviu Savu
, et al.
소스
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
. 878(30)
Full Text (ScienceDirect)
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7 .
Validation of Bioanalytical Methods; Investigation of Back- Conversion in Incurred Pharmacokinetic Samples
저자
by
Adelina Moise
;
Silviu Savu Ariana Tudoroniu
;
Adriana Iordachescu
;
Luigi Silvestro
;
Simona Rizea Savu
.
소스
Journal of Analytical & Bioanalytical Techniques
.
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7 .
ICP-MS Coupling to HPLC to Quantify Unknown Metabolite of Drugs in Biological Fluids
저자
by
Martin Maurer
;
Adriana Iordachescu
;
Simona Rizea Savu
;
Luigi Silvestro
;
Ariana Tudoroniu
.
소스
Journal of Analytical & Bioanalytical Techniques
.
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