Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2022 Mar 28;12(7):3079-3083.
doi: 10.7150/thno.71788. eCollection 2022.

Theranostics approach in drug development: is there study efficiency when the prevalence of the molecular target is very high?

Sue-Jane Wang  1 , Anthony Fotenos  2 , Shane C Masters  2 , Louis Marzella  2
Affiliations
Editorial

Theranostics approach in drug development: is there study efficiency when the prevalence of the molecular target is very high?

Sue-Jane Wang et al. Theranostics. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have declared that no competing interest exists.

Figures

Figure 1
Figure 1
The % of sample size saving when molecular target is predictive of treatment effect
Figure 2
Figure 2
The % of sample size saving when molecular target is prognostic of disease and/or predictive of treatment effect.
See this image and copyright information in PMC

References

    1. U.S. Food and Drug Administration Guidance for Industry on “Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and interpretation of Clinical Studies”. https://www.fda.gov/regulatory-information/search-fda-guidance-documents....
    1. Herrmann K, Schwaiger M, Lewis JS, Soloman SB, McNeil BJ, Baumann M. et al. Radiotheranostics: a roadmap for future development. Lancet Oncol. 2020;21:e146–156. - PMC - PubMed
    1. U.S. FDA Guidance for Industry. Enrichment strategies for clinical trials to support approval of human drugs and biological products. https://www.fda.gov/regulatory-information/search-fda-guidance-documents....
    1. U.S. Food and Drug Administration Companion Diagnostics website. https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagn....
    1. Keytruda (pembrolizumab) injection for intravenous use, highlights of prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s120lbl.pdf.

Publication types