Translation of Radiopharmaceuticals from Bench to Bedside: Regulatory and Manufacturing Issues

Knapp, F. F.; Dash, Ashutosh

doi:10.1007/978-81-322-2607-9_17

Cited by 3 publications

(1 citation statement)

References 35 publications

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“…Before a new radiopharmaceutical may be introduced in the clinic, a range of assessments (Figure 9) are required [245,247,289]. An investigational medicinal product dossier (IMPD) is required for regulatory boards.…”

Section: Data Required For Clinical Translationmentioning

confidence: 99%

A perspective on the radiopharmaceutical requirements for imaging and therapy of glioblastoma

Bolcaen¹,

Kleynhans²,

Nair³

et al. 2021

Theranostics

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Despite numerous clinical trials and pre-clinical developments, the treatment of glioblastoma (GB) remains a challenge. The current survival rate of GB averages one year, even with an optimal standard of care. However, the future promises efficient patient-tailored treatments, including targeted radionuclide therapy (TRT). Advances in radiopharmaceutical development have unlocked the possibility to assess disease at the molecular level allowing individual diagnosis. This leads to the possibility of choosing a tailored, targeted approach for therapeutic modalities. Therapeutic modalities based on radiopharmaceuticals are an exciting development with great potential to promote a personalised approach to medicine. However, an effective targeted radionuclide therapy (TRT) for the treatment of GB entails caveats and requisites. This review provides an overview of existing nuclear imaging and TRT strategies for GB. A critical discussion of the optimal characteristics for new GB targeting therapeutic radiopharmaceuticals and clinical indications are provided. Considerations for target selection are discussed, i.e. specific presence of the target, expression level and pharmacological access to the target, with particular attention to blood-brain barrier crossing. An overview of the most promising radionuclides is given along with a validation of the relevant radiopharmaceuticals and theranostic agents (based on small molecules, peptides and monoclonal antibodies). Moreover, toxicity issues and safety pharmacology aspects will be presented, both in general and for the brain in particular.

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Section: Data Required For Clinical Translationmentioning

confidence: 99%

A perspective on the radiopharmaceutical requirements for imaging and therapy of glioblastoma

Bolcaen¹,

Kleynhans²,

Nair³

et al. 2021

Theranostics

View full text Add to dashboard Cite

show abstract

Non-oncological applications of RGD-based single-photon emission tomography and positron emission tomography agents

Ebenhan

Kleynhans

Zeevaart

et al. 2020

Eur J Nucl Med Mol Imaging

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Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation

Dhoundiyal,

Srivastava,

Kumar

et al. 2024

Eur J Med Res

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This review article explores the dynamic field of radiopharmaceuticals, where innovative developments arise from combining radioisotopes and pharmaceuticals, opening up exciting therapeutic possibilities. The in-depth exploration covers targeted drug delivery, delving into passive targeting through enhanced permeability and retention, as well as active targeting using ligand-receptor strategies. The article also discusses stimulus-responsive release systems, which orchestrate controlled release, enhancing precision and therapeutic effectiveness. A significant focus is placed on the crucial role of radiopharmaceuticals in medical imaging and theranostics, highlighting their contribution to diagnostic accuracy and image-guided curative interventions. The review emphasizes safety considerations and strategies for mitigating side effects, providing valuable insights into addressing challenges and achieving precise drug delivery. Looking ahead, the article discusses nanoparticle formulations as cutting-edge innovations in next-generation radiopharmaceuticals, showcasing their potential applications. Real-world examples are presented through case studies, including the use of radiolabelled antibodies for solid tumors, peptide receptor radionuclide therapy for neuroendocrine tumors, and the intricate management of bone metastases. The concluding perspective envisions the future trajectory of radiopharmaceuticals, anticipating a harmonious integration of precision medicine and artificial intelligence. This vision foresees an era where therapeutic precision aligns seamlessly with scientific advancements, ushering in a new epoch marked by the fusion of therapeutic resonance and visionary progress. Graphical Abstract

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Translation of Radiopharmaceuticals from Bench to Bedside: Regulatory and Manufacturing Issues

Cited by 3 publications

References 35 publications

A perspective on the radiopharmaceutical requirements for imaging and therapy of glioblastoma

A perspective on the radiopharmaceutical requirements for imaging and therapy of glioblastoma

Non-oncological applications of RGD-based single-photon emission tomography and positron emission tomography agents

Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation

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