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Drug Safety
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May 4, 2018
Challenges and Opportunities for the Traceability of (Biological) Medicinal Products
Kevin Klein, Pieter Stolk
Frontiers in Medicine
|
April 29, 2024
Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals
Kevin Klein, Jens Heisterberg, Pieter Stolk
Drug Safety
|
December 25, 2019
The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK
Kevin Klein, Lorna Hazell, Pieter Stolk, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
December 6, 2022
The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries
Kevin Klein, Mümün Gencoglu, Jens Heisterberg, et al.
Therapeutic Innovation & Regulatory Science
|
February 3, 2020
A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways
Lawrence Liberti, Neil McAuslane, Pieter Stolk, et al.
Drug Discovery Today
|
April 16, 2021
Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines
Kevin Klein, Pieter Stolk, Marie Louise De Bruin, et al.
Drug Discovery Today
|
September 15, 2018
The future of drug development: the paradigm shift towards systems therapeutics
Meindert Danhof, Kevin Klein, Pieter Stolk, et al.
Bulletin of the World Health Organization
|
November 28, 2006
Rare essentials: drugs for rare diseases as essential medicines
Pieter Stolk, Marjolein J C Willemen, Hubert G M Leufkens
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
December 2, 2015
Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers
Kevin Klein, Marie L De Bruin, Andre W Broekmans, et al.
Frontiers in Medicine
|
July 19, 2021
The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency
Marieke J H J Dekker, Pieter Stolk, Anna M G Pasmooij
Page
of 4
Search research articles
Search
Showing results (1-10 of 32) with videos related to
Sort By:
Page
of 4
Drug Safety
|
May 4, 2018
Challenges and Opportunities for the Traceability of (Biological) Medicinal Products
Kevin Klein, Pieter Stolk
Frontiers in Medicine
|
April 29, 2024
Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals
Kevin Klein, Jens Heisterberg, Pieter Stolk
Drug Safety
|
December 25, 2019
The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK
Kevin Klein, Lorna Hazell, Pieter Stolk, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
December 6, 2022
The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries
Kevin Klein, Mümün Gencoglu, Jens Heisterberg, et al.
Therapeutic Innovation & Regulatory Science
|
February 3, 2020
A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways
Lawrence Liberti, Neil McAuslane, Pieter Stolk, et al.
Drug Discovery Today
|
April 16, 2021
Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines
Kevin Klein, Pieter Stolk, Marie Louise De Bruin, et al.
Drug Discovery Today
|
September 15, 2018
The future of drug development: the paradigm shift towards systems therapeutics
Meindert Danhof, Kevin Klein, Pieter Stolk, et al.
Bulletin of the World Health Organization
|
November 28, 2006
Rare essentials: drugs for rare diseases as essential medicines
Pieter Stolk, Marjolein J C Willemen, Hubert G M Leufkens
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
December 2, 2015
Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers
Kevin Klein, Marie L De Bruin, Andre W Broekmans, et al.
Frontiers in Medicine
|
July 19, 2021
The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency
Marieke J H J Dekker, Pieter Stolk, Anna M G Pasmooij
Page
of 4