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Expert Review of Molecular Diagnostics, 2015
Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics.
Donna M, Roscoe +2 more
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Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics.
Donna M, Roscoe +2 more
openaire +2 more sources
Companion and complementary diagnostics for infectious diseases
Expert Review of Molecular Diagnostics, 2020Companion diagnostics (CDx) are important in oncology therapeutic decision-making, but specific regulatory-approved CDx for infectious disease treatment are officially lacking. While not approved as CDx, several ID diagnostics are used as CDx. The diagnostics community, manufacturers, and regulatory agencies have made major efforts to ensure that ...
Peter J, Dailey +2 more
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Diagnostic and treatment companion
Veterinary Record, 2013Canine and Feline Dermatology Drug Handbook Sandra N. Koch. Sheila M. F. Torres. Donald C. Plumb 464 pages, paperback, £39.99. Wiley-Blackwell. 2012. ISBN 978 1 4051 9896 7 ![Graphic][1] WHEN this book dropped through the door I pondered its purpose in life. I have the ‘BSAVA Manual of Dermatology’ and a well-thumbed copy of the ‘BSAVA Formulary’ is
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The evolving potential of companion diagnostics
Scandinavian Journal of Clinical and Laboratory Investigation, 2016The scope of companion diagnostics in cancer has undergone significant shifts in the past few years, with increased development of targeted therapies and novel testing platforms. This has provided new opportunities to effect unprecedented paradigm shifts in the application of personalized medicine principles for patients with cancer.
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Regulatory Considerations and Companion Diagnostics
2018The combination of a small molecule and a biologic in an ADC has consequences for regulatory requirements and guidances with respect to nonclinical evaluation as well as clinical development. The complexity of ADCs with regards to manufacturing and analytics presents additional challenges from the regulatory perspective.
Elizabeth VanAlphen, Omar Perez
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[Companion Diagnostics for Thrombotic Disease].
Rinsho byori. The Japanese journal of clinical pathology, 2016In recent years, thrombotic disease, including myocardial infarction and ischemic stroke, has rapidly increased in Japan. To treat and prevent thromboembolism, warfarin has been commonly prescribed for a long period as an oral anticoagulant. However, it is difficult to define an appropriate warfarin dose because of large inter-individual variability in
Yuya, Masuda +2 more
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Companion Diagnostic Reimbursement
Genetic Engineering & Biotechnology News, 2021openaire +1 more source
Companion Diagnostics and the Drug–Diagnostic Codevelopment Model
Drug Development Research, 2012Abstract Preclinical Research The concept of using a predictive or selective diagnostic assay in relation to drug development goes back to the 1970s when the selective estrogen receptor modulator, tamoxifen (AstraZeneca) was developed for metastatic breast cancer.
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Integrative oncology: Addressing the global challenges of cancer prevention and treatment
Ca-A Cancer Journal for Clinicians, 2022Jun J Mao,, Msce +2 more
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