Thursday, June 23, 2011
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Phase I: Initial Pharmacological Evaluation. Determines the safe dosage level for humans. The medication is given to volunteers at gradual doses. The first sign of toxicity is noted. Dosage levels below the toxic dose level are considered safe.
• Phase II: Limited Controlled Evaluation. Determines the therapeutic range for humans. Volunteers who have the disease or disorder are given the medication at gradual doses and are examined to determine the dose that provides the therapeutic effect.
• Phase III: Extended Clinical Evaluation. Determines the effects of the medication on a large group of patients who have the disease or disorder. If the medication proves effective, then the pharmaceutical manufacturer submits a New Drug Application (NDA) to the Food and Drug Administration for approval to market the medication.
• Phase IV: Post Marketing Surveillance Trial. Determines ongoing safety of the medication after the medication is being prescribed by healthcare providers.
Posted in: Clinical Research
good work santhosh .. keep it up..
ReplyDeletei need some info. on requirements and guide lines on clinical trials for import and manufacture of drug substances as per D&C act.
clinical trials, study design, documentation and interpretation.
Thank you very much......I will give the info what you requested asap..meanwhile you could post some valuable stuff on
ReplyDeletehttps://www.facebook.com/home.php?sk=group_156030964467511&ap=1
This is a group for all the pharmacy people so your info could be valuable for so many people.