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Springer电子图书(1)
CNKI学位论文(65)
知网期刊论文(67)
在“
SpringerLink电子期刊
”中,
命中:
14
条,耗时:小于0.01 秒
在所有数据库中总计命中:
133
条
1.
Accelerating
Regulated
Bioanalysis
for Biotherapeutics: Case Examples Using a Microfluidic Ligand Binding Assay Platform
作者:
Rong Liu
;
Brian Hoffpauir
;
Shannon D Chilewski
;
Janice Gamberdella…
关键词:
KEY WORDSGyrolab™ xP
;
ligand binding assay
;
regulated
bioanalysis
;
sample analysis
;
study validation
刊名:The AAPS Journal
出版年:2017
2.
Sample Management: Recommendation for Best Practices and Harmonization from the Global
Bioanalysis
Consortium Harmonization Team
作者:
Michael J. Redrup
;
Harue Igarashi
;
Jay Schaefgen
;
Jenny Lin…
刊名:The AAPS Journal
出版年:2016
3.
Tiered Approaches to Chromatographic Bioanalytical Method Performance Evaluation: Recommendation for Best Practices and Harmonization from the Global
Bioanalysis
Consortium Harmonization Team
作者:
S. Lowes (1)
R. Hucker (2)
M. Jemal (3)
J. C. Marini (4)
V. M. Rezende (5)
R. Shoup (6)
P. Singhal (7)
P. Timmerman (8)
T. Yoneyama (9)
N. Weng (10)
D. Zimmer (11)
1. Bioanalytical and ADME Labs
;
Quintiles
;
19 Brown Road
;
Ithaca
;
New York
;
14850
;
USA
2. A4P Consulting Ltd.
;
Discovery Park
;
Sandwich
;
Kent
;
CT13 9ND
;
UK
3. 931 Edinburg Road
;
Hamilton Square
;
New Jersey
;
08690
;
USA
4. Biologics Clinical Pharmacology
;
Janssen Research and Development
;
LLC
;
1400 McKean Road
;
Spring House
;
Pennsylvania
;
19477
;
USA
5. Department of Hematology
;
School of Medicine
;
University of S茫o Paulo
;
S茫o Paulo
;
Brazil
6. AIT Bioscience
;
LLC
;
7840 Innovation Blvd
;
Indianapolis
;
Indiana
;
46278
;
USA
7. Alkem Laboratories Ltd
;
C-17/7
;
MIDC Industrial Estate
;
Taloja
;
Navi Mumbai
;
Mumbai
;
410208
;
India
8. Janssen Research & Development
;
Turnhoutseweg 30
;
2340
;
Beerse
;
Belgium
9. Drug Metabolism and Pharmacokinetics Research Laboratories
;
Pharmaceutical Research Division
;
Takeda Pharmaceutical Company Limited
;
26-1
;
Muraoka-Higashi 2-Chome
;
Fujisawa
;
Kanagawa
;
251-8555
;
Japan
10. Pharmacokinetics
;
Dynamics & Metabolism
;
Janssen Research and Development
;
1400 McKean Road
;
Spring House
;
Pennsylvania
;
19477
;
USA
11. Zimmer BioAnalytics & More
;
St. Alban-Ring 282
;
CH-4052
;
Basel
;
Switzerland
关键词:
bioanalysis
;
chromatographic
;
regulated
;
tiered approaches
刊名:The AAPS Journal
出版年:2015
4.
Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global
Bioanalysis
Consortium Harmonization Team
作者:
Eric Fluhler (1) (12)
Faye Vazvaei (2)
Puran Singhal (3)
Petra Vinck (4)
Wenkui Li (5)
Jignesh Bhatt (6)
Theo de Boer (7)
Ajai Chaudhary (8)
Masahiro Tangiuchi (9)
Vinicius Rezende (10)
Dafang Zhong (11)
关键词:
harmonization
;
incurred sample reanalysis
;
regulated
bioanalysis
;
repeat analysis
刊名:The AAPS Journal
出版年:2014
5.
Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples
作者:
Eliza N. Fung
;
Anne-Fran?oise Aubry
;
Alban Allentoff
;
Qin C. Ji
关键词:
hemolyzed sample/haemolyzed sample
;
hyperlipemic sample
;
internal standard peak area/internal standard responses
;
LC
;
MS/MS
;
regulated
bioanalysis
;
risk assessment
刊名:The AAPS Journal
出版年:2015
6.
Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics
作者:
Rand Jenkins
;
Jeffrey X. Duggan
;
Anne-Fran?oise Aubry
;
Jianing Zeng…
关键词:
affinity capture mass spectrometry
;
industry white paper
;
method validation
;
protein LC
;
MS/MS quantification
;
regulated
bioanalysis
刊名:The AAPS Journal
出版年:2015
7.
Stability: Recommendation for Best Practices and Harmonization from the Global
Bioanalysis
Consortium Harmonization Team
作者:
Nico van de Merbel (1)
Natasha Savoie (2)
Manish Yadav (3)
Yoshiaki Ohtsu (4)
Joleen White (5)
Maria Francesca Riccio (6)
Kelly Dong (7)
Ronald de Vries (8)
Julie Diancin (9)
关键词:
GBC
;
regulated
bioanalysis
;
stability assessment
刊名:The AAPS Journal
出版年:2014
8.
Automation Practices in Large Molecule
Bioanalysis
: Recommendations from Group L5 of the Global Bioanalytical Consortium
作者:
Ago Ahene (1)
Claudio Calonder (2)
Scott Davis (3)
Joseph Kowalchick (4)
Takahiro Nakamura (5)
Parya Nouri (6)
Igor Vostiar (7)
Yang Wang (8)
Jin Wang (9)
关键词:
automation
;
documentation
;
large molecule
bioanalysis
;
robotic system
刊名:The AAPS Journal
出版年:2014
9.
Retrospective Data Analysis and Proposal of a Practical Acceptance Criterion for Inter-laboratory Cross-validation of Bioanalytical Methods Using Liquid Chromatography/Tandem Mass Spectrometry
作者:
Tomoki Yoneyama (1)
Takashi Kudo (1)
Fumihiro Jinno (1)
Eric R. Schmidt (2)
Takahiro Kondo (1)
关键词:
acceptance criterion
;
cross
;
validation
;
Guideline on bioanalytical method validation (BMV)
;
inter
;
laboratory reliability
;
regulated
bioanalysis
刊名:The AAPS Journal
出版年:2014
10.
Anidulafungin—challenges in development and validation of an LC-MS/MS bioanalytical method validated for
regulated
clinical studies
作者:
Tanja Alebic-Kolbah (1) tanja.alebic-kolbah@pfizer.com
Michael S. Modesitt (2)
关键词:
Anidulafungin – HPLC
;
MS/MS – Anidulafungin open
;
ring form – Pediatric blood collection –
Regulated
bioanalysis
– Validation
刊名:Analytical and Bioanalytical Chemistry
出版年:2012
1
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