YEAR IN BIOANALYSIS
CONTENTS
Editorials 1
67
Reflections on 2015 Regulatory Bioanalysis – regulation applications and deficiency letters A Lévesque & S Lachance
5 Microsampling – a look back at 2015 N Spooner
Top 10 Bioanalysis articles of 2015
9 MALDI-MS imaging for the study of tissue pharmacodynamics and toxicodynamics E Patel, LM Cole, R Bradshaw, A Batubara, CA Mitchell, S Francese & MR Clench
21
Justifying the lack of incurred sample reproducibility in a study: considerations and strategies S Gagnon-Carignan, S Lachance, A Saint-Laurent, M Gendron & A Lévesque
29 Comparative immunogenicity assessment: a critical consideration for biosimilar development PM Liu, L Zou, C Sadhu, WD Shen & S Nock
43
ELISA microplate: a viable immunocapture platform over magnetic beads for immunoaffinity-LC–MS/MS quantitation of protein therapeutics? W Yang, R Kernstock, N Simmons & A Alak
55 A device for dried blood microsampling in quantitative bioanalysis: overcoming the issues associated with blood hematocrit N Spooner, P Denniff, L Michielsen, R De Vries, QC Ji, ME Arnold, K Woods, EJ Woolf, Y Xu, V Boutet, P Zane, S Kushon & JB Rudge
www.future-science.com
Bioanalytical method validation considerations for LC–MS/MS assays of therapeutic proteins JX Duggan, F Vazvaei & R Jenkins
75
Integration of bioanalytical measurements using PK–PD modeling and simulation: implications for antibody–drug conjugate development A Khot, S Sharma & DK Shah
91 Antibody–drug conjugates nonclinical support: from early to late nonclinical bioanalysis using ligand-binding assays S Kumar, LE King, TH Clark & B Gorovits
107 Surrogate matrix: opportunities and challenges for tissue sample analysis S Ho & H Gao
123 Development and validation of an ELISA for quantification of soluble IFN-β receptor: assessment in multiple sclerosis T Órpez-Zafra, J Pavía, MJ Pinto- Medel, I Hurtado-Guerrero, JL Rodriguez-Bada, EM Montañez, Ó Fernández, L Leyva, B Oliver-Martos
Interviews
20 Video interview with Chris Beaver (inVentiv Health)
39 63
Interview with Shane Needham (Alturas Analytics)
Interview with Luigi Silvestro (3S-Pharmacological Consultation & Research)
105 Interview with Lei Xiong (Sciex)
Company Profiles 141 3S Pharma; Alturas Analytics; Boehringer-Ingelheim; Gyros; inVentiv Health; Sciex; SGS; Waters
© 2016 Future Science Ltd ISSN 1757-6180
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