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AUTHOR CONTRIBUTION FORM Title Clinical and biological characterization of patients with low (0.12%) JAK2V617F allele burden at diagnosis. First author Eric Lip pert According to the International
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What is clinical and biological characterization?
Clinical and biological characterization refers to the detailed description and analysis of the clinical and biological properties of a particular substance or product.
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The entity or individual responsible for the development, manufacturing, or distribution of the substance or product is required to file clinical and biological characterization.
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Clinical and biological characterization can be filled out by providing detailed information on the clinical and biological properties of the substance or product using the designated form or template.
What is the purpose of clinical and biological characterization?
The purpose of clinical and biological characterization is to provide regulators and stakeholders with essential information about the properties of a substance or product, including its safety and efficacy.
What information must be reported on clinical and biological characterization?
The information that must be reported on clinical and biological characterization includes details on the physical, chemical, biological, and toxicological properties of the substance or product, as well as any relevant clinical data.
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