Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?

Category: Special Report
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Author byline as per print journal: Professor Irene Krämer, PhD; Judith Thiesen, PhD

Abstract:
Monoclonal antibodies and cell therapies play an increasingly significant role in anticancer therapy, but small molecules remain an essential part of combination chemotherapy. Despite the publication of many studies on the extended stability of small molecule preparations, not all licensed medicinal products and stability-determining factors are covered.

During the last decades, anticancer therapy has changed significantly regarding the types and mechanisms of medicinal products used. Monoclonal antibodies and cell therapies play an increasingly important role. However, small molecules with non-specific antineoplastic activity remain an indispensable part of combination chemotherapy. Modern anticancer therapies comprise non-specific antineoplastic agents, targeted anticancer medication, and advanced therapy medicinal products.

Submitted: 26 April 2024; Revised: 9 May 2024; Accepted: 15 May 2024; Published online first: 29 May 2024

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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