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SECTIONIALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, NEW DELHI110 029 NOTICE INVITING TENDERS (NIT)Advertised Limited Tender Enquiry No: 47/H/Exon Skipping Of Exon 45 ( Inj. Casimersen )/202223
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Collect data on the safety and tolerability of the drug or treatment through clinical trials.
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Evaluate any adverse reactions or side effects reported by participants during the trial.
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Safety tolerability refers to the assessment of the safety of a substance, focusing on the adverse effects and how well individuals tolerate them. Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and excreted in the body.
Researchers, pharmaceutical companies, and sponsors of clinical trials are typically required to file safety tolerability and pharmacokinetics data as part of their regulatory submissions.
To fill out safety tolerability and pharmacokinetics submissions, one must collect and analyze relevant data, draft reports that include study design, results, and conclusions, and then submit these findings in accordance with regulatory guidelines.
The purpose is to ensure the safety and efficacy of drugs, to evaluate their effects on patients, and to inform regulatory agencies about the risks and benefits associated with their use.
Reportable information includes adverse events, dosage, route of administration, time course of drug concentration in the body, and demographics of study participants.
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