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Other key topics will be discussed, including regulatory guidance for the evaluation of biosimilars, clinical trial design considerations, and whether data submitted for the approval of a biosimilar for one indication can be extrapolated to other indications for which the reference biologic is approved.
Further, we argue that immunosuppressive agents shown to be effective and safe for one indication generally transfer well to another.
An alternative approach is 'Drug Repurposing' wherein clinically approved drugs for one indication are re-explored for new applications.
Repurposing, also called repositioning, reprofiling, or rediscovering, refers to the concept or process of taking a drug developed for one indication and applying it to another.
The organization stated that "a biosimilar proven effective and safe for one indication may not necessarily be effective and safe for a second indication for which the reference biologic has been shown to be safe and effective".
Newer agents that have reached the clinic for one indication may well be/have been applied to others, while there are other agents, effective in animal models, that have yet to be translated to the clinical setting.
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Referencing the US Food and Drug Administration FDAapprovedved labels allow the adoption of one indication for each drug.
Eighty-four oft of 102 chest X-ray scans were taken for only one indication, with 36/84 for diagnosis of chest pathology.
If a drug was approved for more than one indication (e.g. ramipril for hypertension, heart failure, diabetic nephropathy, and others) and conversion factors of different indications differed, this fact was indicated.
For episodes where more than one indication for fluid resuscitation was provided, these were classified according to a predetermined hierarchy (see Additional File 2).
Out of 426 primary care physicians, 287 (67%) opted for dyspepsia as the number one indication for investigating H. pylori, followed by gastroesophageal reflux diseases (GERD), gastritis, gastric and duodenal ulcers, iron deficiency anemia.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com