| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products
|
Schiestl, Martin
|
|
2011
|
|
5 |
p. 297-299
3 p.
|
artikel
|
| 2 |
Acknowledgements
|
|
|
2011
|
|
5 |
p. 251-
1 p.
|
artikel
|
| 3 |
A collaborative study to establish the 1st WHO International Standard for Epstein–Barr virus for nucleic acid amplification techniques
|
Fryer, Jacqueline F.
|
|
2016
|
|
5 |
p. 423-433
11 p.
|
artikel
|
| 4 |
Adjuvant effect of bovine heat shock protein 70 on piroplasm surface protein, p33, of Theileria sergenti
|
Jeong, Wooseog
|
|
2009
|
|
5 |
p. 282-287
6 p.
|
artikel
|
| 5 |
Adventitious agents in viral vaccines: Lessons learned from 4 case studies
|
Petricciani, John
|
|
2014
|
|
5 |
p. 223-236
14 p.
|
artikel
|
| 6 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2009
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 7 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2016
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 8 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2015
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 9 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2014
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 10 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2008
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 11 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2010
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 12 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2011
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 13 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2013
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 14 |
Aims and Scope/Editorial Board/Publishing Details
|
|
|
2012
|
|
5 |
p. IFC-
1 p.
|
artikel
|
| 15 |
An Indian manufacturer’s perspective for harmonization of guidelines for similar biotherapeutic products
|
Babu, P.V. Cherish
|
|
2011
|
|
5 |
p. 300-303
4 p.
|
artikel
|
| 16 |
Announcement
|
|
|
2011
|
|
5 |
p. I-
1 p.
|
artikel
|
| 17 |
Antibody-drug conjugates for cancer therapy: The technological and regulatory challenges of developing drug-biologic hybrids
|
Hamilton, Gregory S.
|
|
2015
|
|
5 |
p. 318-332
15 p.
|
artikel
|
| 18 |
A proposed protocol for the standardized preparation of PRF membranes for clinical use
|
Kobayashi, Mito
|
|
2012
|
|
5 |
p. 323-329
7 p.
|
artikel
|
| 19 |
Assessment of the impact of solvent/detergent treatment on the quality and potency of a whole IgG equine antivenom
|
Segura, Álvaro
|
|
2009
|
|
5 |
p. 306-312
7 p.
|
artikel
|
| 20 |
A study on the use of caprylic acid and ammonium sulfate in combination for the fractionation of equine antivenom F(ab′)2
|
Simsiriwong, Pavinee
|
|
2012
|
|
5 |
p. 338-344
7 p.
|
artikel
|
| 21 |
Avian IgY antibodies and their recombinant equivalents in research, diagnostics and therapy
|
Spillner, Edzard
|
|
2012
|
|
5 |
p. 313-322
10 p.
|
artikel
|
| 22 |
Biosimilars and non-innovator biotherapeutics in India: An overview of the current situation
|
Malhotra, Hemant
|
|
2011
|
|
5 |
p. 321-324
4 p.
|
artikel
|
| 23 |
Biosimilars clinical development program: Confirmatory clinical trials: A virtual/simulated case study comparing equivalence and non-inferiority approaches
|
Fletcher, Mark P.
|
|
2011
|
|
5 |
p. 270-277
8 p.
|
artikel
|
| 24 |
Biosimilars – Global issues, national solutions
|
Knezevic, Ivana
|
|
2011
|
|
5 |
p. 252-255
4 p.
|
artikel
|
| 25 |
Biotechnological products in Pan American Health Organization (PAHO): Regional efforts towards harmonization of regulation
|
Pombo, María L.
|
|
2011
|
|
5 |
p. 348-
1 p.
|
artikel
|
| 26 |
Calibration of replacement international standards of diphtheria and tetanus toxoids for use in flocculation test
|
Preneta-Blanc, R.
|
|
2008
|
|
5 |
p. 315-326
12 p.
|
artikel
|
| 27 |
Cell therapy clinical trials in Germany – Critical aspects of quality data content
|
Renner, Matthias
|
|
2015
|
|
5 |
p. 429-432
4 p.
|
artikel
|
| 28 |
China’s perspective on similar biotherapeutic products
|
Liang, Chenggang
|
|
2011
|
|
5 |
p. 312-316
5 p.
|
artikel
|
| 29 |
Clinical programs in the development of similar biotherapeutic products: Rationale and general principles
|
Berghout, Alexander
|
|
2011
|
|
5 |
p. 293-296
4 p.
|
artikel
|
| 30 |
Coexpression of double or triple copies of the rabies virus glycoprotein gene using a ‘self-cleaving’ 2A peptide-based replication-defective human adenovirus serotype 5 vector
|
Tan, Yeping
|
|
2010
|
|
5 |
p. 586-593
8 p.
|
artikel
|
| 31 |
Collaborative study for the calibration of a replacement international standard for diphtheria toxoid adsorbed
|
Stickings, Paul
|
|
2010
|
|
5 |
p. 529-538
10 p.
|
artikel
|
| 32 |
Collagen-graft mixed cellulose esters membrane maintains undifferentiated morphology and markers of potential pluripotency in feeder-free culture of induced pluripotent stem cells
|
Lotfalah Moradi, Sadegh
|
|
2016
|
|
5 |
p. 387-393
7 p.
|
artikel
|
| 33 |
Comparative studies on drug binding to the purified and pharmaceutical-grade human serum albumins: Bridging between basic research and clinical applications of albumin
|
Ashrafi-Kooshk, Mohammad Reza
|
|
2015
|
|
5 |
p. 333-343
11 p.
|
artikel
|
| 34 |
Comparison between S+L− assay and LacZ marker rescue assay for detecting replication-competent gammaretroviruses
|
Hashimoto-Gotoh, A.
|
|
2015
|
|
5 |
p. 363-368
6 p.
|
artikel
|
| 35 |
Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim
|
Skrlin, A.
|
|
2010
|
|
5 |
p. 557-566
10 p.
|
artikel
|
| 36 |
Concept of biosimilar products in Jordan
|
Haddadin, Rania Dakhlallah
|
|
2011
|
|
5 |
p. 333-335
3 p.
|
artikel
|
| 37 |
Contributors
|
|
|
2011
|
|
5 |
p. 250-
1 p.
|
artikel
|
| 38 |
Corrigendum to “Isolation of infective promastigotes of Leishmania major from long-term culture by cocultivation with macrophage cell line” [Biologicals 33 (2005) 257–260]
|
Mirjalili, Ali
|
|
2008
|
|
5 |
p. 344-
1 p.
|
artikel
|
| 39 |
CT-P13 (Inflectra™, Remsima™) monitoring in patients with inflammatory bowel disease
|
Schulze, Kornelius
|
|
2016
|
|
5 |
p. 463-466
4 p.
|
artikel
|
| 40 |
Current development in regulation of similar biotherapeutic products in Brazil
|
Castanheira, Laura Gomes
|
|
2011
|
|
5 |
p. 308-311
4 p.
|
artikel
|
| 41 |
Current regulatory and scientific considerations for approving biosimilars in Iran
|
Hadavand, Naser
|
|
2011
|
|
5 |
p. 325-327
3 p.
|
artikel
|
| 42 |
Current status and future directions of post-marketing vaccine safety monitoring with focus on USA and Europe
|
Bonhoeffer, Jan
|
|
2012
|
|
5 |
p. 393-397
5 p.
|
artikel
|
| 43 |
Determinants of immunogenic response to protein therapeutics
|
Singh, Satish K.
|
|
2012
|
|
5 |
p. 364-368
5 p.
|
artikel
|
| 44 |
Determination of critical quality attributes for monoclonal antibodies using quality by design principles
|
Alt, Nadja
|
|
2016
|
|
5 |
p. 291-305
15 p.
|
artikel
|
| 45 |
Development and validation of an ATP method for rapid estimation of viable units in lyophilised BCG Danish 1331 vaccine
|
Jensen, Sten E.
|
|
2008
|
|
5 |
p. 308-314
7 p.
|
artikel
|
| 46 |
Development and validation of a serological potency test for the release of Leptospira vaccines – Requirements in the European Union
|
Balks, Elisabeth
|
|
2013
|
|
5 |
p. 325-329
5 p.
|
artikel
|
| 47 |
Development of in vitro assays for measuring the relative potency of leptospiral bacterins containing serogroups canicola, grippotyphosa, icterohaemorrhagiae, and pomona
|
Ruby, K.W.
|
|
2013
|
|
5 |
p. 308-314
7 p.
|
artikel
|
| 48 |
Development of Leptospira in vitro potency assays: EU/industry experience and perspectives
|
Klaasen, H.L.B.M.
|
|
2013
|
|
5 |
p. 315-322
8 p.
|
artikel
|
| 49 |
Effects of anti-TNF therapy on glucose metabolism in patients with ankylosing spondylitis, psoriatic arthritis or juvenile idiopathic arthritis
|
da Silva, Bárbara Santos Pires
|
|
2010
|
|
5 |
p. 567-569
3 p.
|
artikel
|
| 50 |
Efficient expression of foreign genes in CHO DHFR− cellsby electroporation
|
Lin, Wen-Zhen
|
|
2009
|
|
5 |
p. 277-281
5 p.
|
artikel
|
| 51 |
Endotoxin recovery using limulus amebocyte lysate (LAL) assay
|
Bolden, Jay S.
|
|
2016
|
|
5 |
p. 434-440
7 p.
|
artikel
|
| 52 |
Engineering foot-and-mouth disease virus serotype O IND R2/1975 for one-step purification by immobilized metal affinity chromatography
|
Biswal, Jitendra K.
|
|
2015
|
|
5 |
p. 390-398
9 p.
|
artikel
|
| 53 |
Enhanced efficacy of DNA vaccination against botulinum neurotoxin serotype A by co-administration of plasmids encoding DC-stimulating Flt3L and MIP-3α cytokines
|
Xu, Qing
|
|
2016
|
|
5 |
p. 441-447
7 p.
|
artikel
|
| 54 |
Epidemiological designs for vaccine safety assessment: Methods and pitfalls
|
Andrews, Nick
|
|
2012
|
|
5 |
p. 389-392
4 p.
|
artikel
|
| 55 |
Establishing a control system using QbD principles
|
Kepert, J. Felix
|
|
2016
|
|
5 |
p. 319-331
13 p.
|
artikel
|
| 56 |
Establishment of an equine tetanus antitoxin reference standard for veterinary use in Japan
|
Hirano, Fumiya
|
|
2016
|
|
5 |
p. 374-377
4 p.
|
artikel
|
| 57 |
Establishment of replacement International Standard 13/132 for human antibodies to Toxoplasma gondii
|
Rijpkema, Sjoerd
|
|
2016
|
|
5 |
p. 448-455
8 p.
|
artikel
|
| 58 |
European regulatory framework and practices for veterinary Leptospira vaccine potency testing
|
Bruckner, Lukas
|
|
2013
|
|
5 |
p. 303-304
2 p.
|
artikel
|
| 59 |
Evaluation of a candidate International Standard for Meningococcal Group C polysaccharide
|
Vipond, Caroline
|
|
2012
|
|
5 |
p. 353-363
11 p.
|
artikel
|
| 60 |
Evaluation of antibody levels during simultaneous aflatoxicosis and vaccination against infectious laryngotracheitis in pullets
|
Ebrahimi, Mohammad Majid
|
|
2008
|
|
5 |
p. 327-329
3 p.
|
artikel
|
| 61 |
Evaluation of quantitative anti-F1 IgG and anti-V IgG ELISAs for use as an in vitro-based potency assay of plague vaccine in mice
|
Little, S.F.
|
|
2008
|
|
5 |
p. 287-295
9 p.
|
artikel
|
| 62 |
Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation
|
Knezevic, Ivana
|
|
2011
|
|
5 |
p. 256-261
6 p.
|
artikel
|
| 63 |
Evaluation of similar biotherapeutic products: Scientific and regulatory challenges
|
Griffiths, Elwyn
|
|
2011
|
|
5 |
p. 249-
1 p.
|
artikel
|
| 64 |
Expansion of the in vitro assay for Leptospira potency testing to other serovars: Case study with Leptospira Hardjo
|
Alt, David P.
|
|
2013
|
|
5 |
p. 323-324
2 p.
|
artikel
|
| 65 |
Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan
|
Arato, Teruyo
|
|
2011
|
|
5 |
p. 289-292
4 p.
|
artikel
|
| 66 |
Expression of Chlamydophila psittaci MOMP heat-labile toxin B subunit fusion gene in transgenic rice
|
Zhang, Xiuxiang
|
|
2008
|
|
5 |
p. 296-302
7 p.
|
artikel
|
| 67 |
Extent and content of data for regulatory submissions: First-in-human and marketing authorization – Viewpoint of US industry
|
Harris, Ian Ross
|
|
2015
|
|
5 |
p. 402-405
4 p.
|
artikel
|
| 68 |
Foreword: Quality by Design for monoclonal antibodies: Description of an integrated system
|
Kelley, Brian
|
|
2016
|
|
5 |
p. 281-
1 p.
|
artikel
|
| 69 |
Heparin identification test and purity test for OSCS in heparin sodium and heparin calcium by weak anion-exchange high-performance liquid chromatography
|
Hashii, Noritaka
|
|
2010
|
|
5 |
p. 539-543
5 p.
|
artikel
|
| 70 |
Hepatitis E virus derived from different sources exhibits different behaviour in virus inactivation and/or removal studies with plasma derivatives
|
Yunoki, Mikihiro
|
|
2016
|
|
5 |
p. 403-411
9 p.
|
artikel
|
| 71 |
High-risk human papilloma virus genotypes in cervical carcinoma of Serbian women: Distribution and association with pathohistological findings
|
Stamenković, Miodrag
|
|
2016
|
|
5 |
p. 412-416
5 p.
|
artikel
|
| 72 |
Human antibody Fc deamidation in vivo
|
Liu, Y. Diana
|
|
2009
|
|
5 |
p. 313-322
10 p.
|
artikel
|
| 73 |
Human papillomavirus vaccines: WHO position paper
|
WHO,
|
|
2009
|
|
5 |
p. 338-344
7 p.
|
artikel
|
| 74 |
Identification of immunotherapeutic epitope of E5 protein of human papillomavirus-16: An in silico approach
|
Kumar, Anoop
|
|
2015
|
|
5 |
p. 344-348
5 p.
|
artikel
|
| 75 |
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility
|
Wadhwa, Meenu
|
|
2015
|
|
5 |
p. 298-306
9 p.
|
artikel
|
| 76 |
Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes
|
Knezevic, Ivana
|
|
2015
|
|
5 |
p. 307-317
11 p.
|
artikel
|
| 77 |
Impact of National and International Stem Cell Banking Initiatives on progress in the field of cell therapy
|
Aoi, Takashi
|
|
2015
|
|
5 |
p. 399-401
3 p.
|
artikel
|
| 78 |
Integration of QbD risk assessment tools and overall risk management
|
Kelley, Brian
|
|
2016
|
|
5 |
p. 341-351
11 p.
|
artikel
|
| 79 |
Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)
|
Thorpe, Robin
|
|
2011
|
|
5 |
p. 262-265
4 p.
|
artikel
|
| 80 |
International regulatory requirements for Leptospira vaccine potency testing. Roundtable: Current requirements and opportunity for harmonization
|
Draayer, Hans A.
|
|
2013
|
|
5 |
p. 305-307
3 p.
|
artikel
|
| 81 |
Intra-family differences in efficacy of inactivation of small, non-enveloped viruses
|
Nims, Raymond W.
|
|
2016
|
|
5 |
p. 456-462
7 p.
|
artikel
|
| 82 |
Introduction to the application of QbD principles for the development of monoclonal antibodies
|
Finkler, Christof
|
|
2016
|
|
5 |
p. 282-290
9 p.
|
artikel
|
| 83 |
Isoforms of p63 in corneal stem cells cultured on human amniotic membrane
|
Krishnan, Sasirekha
|
|
2010
|
|
5 |
p. 570-576
7 p.
|
artikel
|
| 84 |
Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use
|
Martín, Patricia Gálvez
|
|
2012
|
|
5 |
p. 330-337
8 p.
|
artikel
|
| 85 |
Leptospirosis: Public health perspectives
|
Guerra, Marta A.
|
|
2013
|
|
5 |
p. 295-297
3 p.
|
artikel
|
| 86 |
Lymphoid lineage differentiation potential of mouse nuclear transfer embryonic stem cells
|
Eslami-Arshaghi, Tarlan
|
|
2015
|
|
5 |
p. 349-354
6 p.
|
artikel
|
| 87 |
Masking of endotoxin in surfactant samples: Effects on Limulus-based detection systems
|
Reich, Johannes
|
|
2016
|
|
5 |
p. 417-422
6 p.
|
artikel
|
| 88 |
Meeting report on protein particles and immunogenicity of therapeutic proteins: Filling in the gaps in risk evaluation and mitigation
|
Carpenter, John
|
|
2010
|
|
5 |
p. 602-611
10 p.
|
artikel
|
| 89 |
Mode of action of adjuvants: Implications for vaccine safety and design
|
Mastelic, Béatris
|
|
2010
|
|
5 |
p. 594-601
8 p.
|
artikel
|
| 90 |
Multiplex RT Q-PCR assay for simultaneous quantification of three viruses used for validation of virus clearance by biopharmaceutical production
|
Lute, Scott
|
|
2009
|
|
5 |
p. 331-337
7 p.
|
artikel
|
| 91 |
Opportunities and strategies to further reduce animal use for Leptospira vaccine potency testing
|
Walker, A.
|
|
2013
|
|
5 |
p. 332-337
6 p.
|
artikel
|
| 92 |
Overview: Core technical elements for early product development, evaluation, and control of human cell-based products
|
Hayakawa, Takao
|
|
2015
|
|
5 |
p. 410-415
6 p.
|
artikel
|
| 93 |
Parametric and non-parametric prediction intervals based phase II control charts for repeated bioassay data
|
Hothorn, L.A.
|
|
2009
|
|
5 |
p. 323-330
8 p.
|
artikel
|
| 94 |
Patterns of binding of aluminum-containing adjuvants to Haemophilus influenzae type b and meningococcal group C conjugate vaccines and components
|
Otto, Robert B.D.
|
|
2015
|
|
5 |
p. 355-362
8 p.
|
artikel
|
| 95 |
Physiologically clotted fibrin – Preparation and characterization for tissue engineering and drug delivery applications
|
Vedakumari, Weslen S.
|
|
2014
|
|
5 |
p. 277-284
8 p.
|
artikel
|
| 96 |
Post-licensure evaluation of vaccine safety: Current status and future directions. Symposium organised by the International Alliance for Biological Standardization (IABS) in Barcelona, Spain, 27–28 April 2011
|
Black, Steven
|
|
2012
|
|
5 |
p. 382-383
2 p.
|
artikel
|
| 97 |
Preclinical safety testing for cell-based products using animals
|
McBlane, James W.
|
|
2015
|
|
5 |
p. 425-428
4 p.
|
artikel
|
| 98 |
Probe-free and sensitive detection of diarrhea-causing pathogens using RT-PCR combined high resolution melting analysis
|
Wang, Hai-Bo
|
|
2016
|
|
5 |
p. 360-366
7 p.
|
artikel
|
| 99 |
Process characterization and Design Space definition
|
Hakemeyer, Christian
|
|
2016
|
|
5 |
p. 306-318
13 p.
|
artikel
|
| 100 |
Production of recombinant non-structural protein-3 hydrophobic domain deletion (NS3ΔHD) protein of bluetongue virus from prokaryotic expression system as an efficient diagnostic reagent
|
Mohanty, Nihar Nalini
|
|
2016
|
|
5 |
p. 352-359
8 p.
|
artikel
|
| 101 |
Product-specific validation of a serological potency test for release of Leptospira vaccines in the European Union
|
Stirling, Catrina
|
|
2013
|
|
5 |
p. 330-331
2 p.
|
artikel
|
| 102 |
Protective effect of pilin protein with alum+naloxone adjuvant against acute pulmonary Pseudomonas aeruginosa infection
|
Banadkoki, Abbas Zare
|
|
2016
|
|
5 |
p. 367-373
7 p.
|
artikel
|
| 103 |
Protective immune-response of aluminium hydroxide gel adjuvanted phage lysate of Brucella abortus S19 in mice against direct virulent challenge with B. abortus 544
|
Jain, Lata
|
|
2015
|
|
5 |
p. 369-376
8 p.
|
artikel
|
| 104 |
QbD implementation and Post Approval Lifecycle Management (PALM)
|
Ohage, Ettore
|
|
2016
|
|
5 |
p. 332-340
9 p.
|
artikel
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| 105 |
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