Pieter Stolk
Overview
Explore the profile of Pieter Stolk including associated specialties, affiliations and a list of published articles.
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Articles
32
Citations
251
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0
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Recent Articles
1.
Klein K, Heisterberg J, Stolk P
Front Med (Lausanne)
. 2024 Apr;
11:1335928.
PMID: 38681047
Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine. Whereas...
2.
Klein K, Gencoglu M, Heisterberg J, Acha V, Stolk P
BioDrugs
. 2022 Dec;
37(2):235-245.
PMID: 36472773
Background: Current knowledge is limited about which manufacturers are active in the global field of biopharmaceutical product development and how many unique follow-on biologics are approved in global markets. Objective:...
3.
Mitratza M, Goodale B, Shagadatova A, Kovacevic V, van de Wijgert J, Brakenhoff T, et al.
Lancet Digit Health
. 2022 Apr;
4(5):e370-e383.
PMID: 35461692
Containing the COVID-19 pandemic requires rapidly identifying infected individuals. Subtle changes in physiological parameters (such as heart rate, respiratory rate, and skin temperature), discernible by wearable devices, could act as...
4.
Leufkens H, Kusynova Z, Aitken M, Hoekman J, Stolk P, Klein K, et al.
Drug Discov Today
. 2022 Apr;
27(8):2252-2260.
PMID: 35364271
The future of medicines is likely determined by an array of scientific, socioeconomic, policy, medical need, and geopolitical factors, with many uncertainties ahead. Here, we report from a scenario project,...
5.
Klein K, Stolk P, Tellner P, Acha V, Montagne S, Stockert I
Ther Innov Regul Sci
. 2022 Feb;
56(2):366-377.
PMID: 35129827
The COVID-19 pandemic required urgency in the development and delivery of effective vaccines and therapeutics; meanwhile, ongoing clinical research, regulation and supply for other much-needed therapeutics and vaccines needed to...
6.
Dekker M, Stolk P, Pasmooij A
Front Med (Lausanne)
. 2021 Jul;
8:619513.
PMID: 34277648
Recently, the use of novel remote monitoring technologies (RMTs) in trials has gained much interest. To facilitate regulatory learning, we evaluated qualification opinions (QOs) and advices (QAs) and scientific advices...
7.
Klein K, Stolk P, De Bruin M, Leufkens H
Drug Discov Today
. 2021 Apr;
26(10):2221-2225.
PMID: 33862191
The continuous scientific, societal, and technological advancements have shifted drug development toward increasingly complex and ever more targeted treatments. This creates new and unprecedented challenges for global regulatory systems. To...
8.
Liberti L, McAuslane N, Stolk P, Breckenridge A, Leufkens H
Ther Innov Regul Sci
. 2020 Feb;
54(1):55-68.
PMID: 32008253
Background: As regulatory agencies come under increased pressure to review medicines of critical importance through efficient regulatory systems to provide equitable access, the benefits of using expedited review pathways are...
9.
Klein K, Hazell L, Stolk P, Shakir S
Drug Saf
. 2019 Dec;
43(3):255-263.
PMID: 31872358
Introduction: Due to the complexity of biologics and the inherent challenges for manufacturing, it is important to know the specific brand name and batch number of suspected biologics in adverse...
10.
Gispen-de Wied C, Weemers J, Boon W, Mol P, Stolk P
Br J Clin Pharmacol
. 2019 Jul;
85(10):2442-2445.
PMID: 31317570
Regulating drugs does not end when market access has been granted. Monitoring drugs over the life cycle has become state of the art, inherent to evolving legislation and societal need....