Day 21 - Bioavailability & Bioequivalence Forms PDF
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Anurag Saro
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Summary
This document details forms related to conducting bioavailability and bioequivalence studies for oral solid dosage forms. It outlines the process of obtaining permission from the regulatory authority in India (CDSCO). The document provides details of several forms, including applications for permission, licenses to import new drugs, and permissions to conduct specific studies.
Full Transcript
Day 21- BABE Hello All, Welcome to Day 21: Learning series of BABE (Bioavailability & Bioequivalence) study for oral solid dosage form from basic to advance. Day 21: Forms related to conducting Bioavailability or Bioequivalence (BABE) studies and the process of receiving permission from the regulat...
Day 21- BABE Hello All, Welcome to Day 21: Learning series of BABE (Bioavailability & Bioequivalence) study for oral solid dosage form from basic to advance. Day 21: Forms related to conducting Bioavailability or Bioequivalence (BABE) studies and the process of receiving permission from the regulatory authority (India (CDSCO)) Forms submitted by the sponsor to the regulatory authority: FORM CT-05: Application for grant of permission to conduct bioavailability or bioequivalence study. This form is used by the sponsor to apply for permission to conduct a bioavailability or bioequivalence study. It includes information about the drug product details, study protocol, and other relevant information. FORM CT-16: Application for grant of license to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. This form is used by the sponsor to apply for a license to import a new drug or investigational new drug. It is required when the sponsor intends to import the drug for use in a clinical trial, bioavailability or bioequivalence study, or for examination, test, and analysis purposes. Forms received by the sponsor from the regulatory authority: FORM CT-07: Permission to conduct bioavailability or bioequivalence study of new drug or investigational new drug. Once the regulatory authority reviews the application (FORM CT-05 and other related documents) and grants permission, they issue this form to the sponsor. It confirms the permission to conduct the bioavailability or bioequivalence study on the specified new drug or investigational new drug. Day 21- BABE FORM CT-17: License to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. After reviewing the application (FORM CT-16 and other relevant documents), if approved, the regulatory authority issues this form to the sponsor. It grants the sponsor a license to import the specified new drug or investigational new drug for use in a clinical trial, bioavailability or bioequivalence study, or for examination, test, and analysis purposes. Along with Form CT-07 & CT-17, Sponsor received the covering letter. Forms Description FORM CT-05 Application for grant of permission to conduct bioavailability or bioequivalence study. FORM CT-16 Application for grant of license to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. FORM CT-07 Permission to conduct bioavailability or bioequivalence study of new drug or investigational new drug. FORM CT-17 License to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. Thanks Regards Anurag Saro
