Detalles de la búsqueda
1.
WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Biologicals
; 76: 1-9, 2022 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-35466023
2.
The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
Biologicals
; 65: 1-9, 2020 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-32224101
3.
Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products.
Biologicals
; 66: 17-20, 2020 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-32536585
4.
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Biologicals
; 65: 50-59, 2020 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-31959504
5.
Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements.
Biologicals
; 62: 1-7, 2019 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-31668453
6.
Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study.
Biologicals
; 62: 8-15, 2019 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-31668854
7.
Regulatory evaluation of biosimilars throughout their product life-cycle.
Bull World Health Organ
; 96(4): 281-285, 2018 Apr 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29695884
8.
WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017.
Biologicals
; 52: 83-91, 2018 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-29289489
9.
Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.
Biologicals
; 43(1): 1-10, 2015 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-25467836
10.
Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.
Biologicals
; 43(5): 298-306, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-26144595
11.
Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes.
Biologicals
; 43(5): 307-17, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-26220918
12.
Review of the current use and evaluation of cell substrates for producing biologicals in selected countries.
Biologicals
; 43(3): 153-7, 2015 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-25707711
13.
The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise.
Biologicals
; 42(2): 128-32, 2014 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-24373974
14.
WHO guidelines on biosimilars: Toward improved access to safe and effective products.
Ann N Y Acad Sci
; 1521(1): 96-103, 2023 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-36694455
15.
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.
BioDrugs
; 36(3): 359-371, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35596890
16.
Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).
Biologicals
; 39(5): 304-7, 2011 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-21880507
17.
WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010.
Biologicals
; 39(5): 349-57, 2011 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-21906959
18.
Development of mRNA Vaccines: Scientific and Regulatory Issues.
Vaccines (Basel)
; 9(2)2021 Jan 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-33498787
19.
Regulatory challenges with biosimilars: an update from 20 countries.
Ann N Y Acad Sci
; 1491(1): 42-59, 2021 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-33222245
20.
WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.
NPJ Vaccines
; 5(1): 52, 2020.
Artículo
en Inglés
| MEDLINE | ID: mdl-32579135