What Are The Contents Of An Ind Application?

1.	What Are The Contents Of An Ind Application?
Answer» The name, CHEMICAL name and structure of the NCE Complete list of components of the drug Quantitative composition of the drug Name and ADDRESS of the supplier of any new drug substance Description of synthesis of any new drug substance Statement of methods, facilities and controls used in manufacture and packaging of the new drug Statement covering all INFORMATION from pre-clinical studies and any clinical studies and experiences With the drug Copies of labels for the drug. Description of scientific training and experience considered appropriate by the sponsor to qualify the investigator as a suitable expert to investigate the drug Names and curriculum vitae of all the INVESTIGATORS An outline of planned methodology to be adopted for the clinical trial

Answer»

The name, CHEMICAL name and structure of the NCE
Complete list of components of the drug
Quantitative composition of the drug
Name and ADDRESS of the supplier of any new drug substance
Description of synthesis of any new drug substance
Statement of methods, facilities and controls used in manufacture and packaging of the new drug
Statement covering all INFORMATION from pre-clinical studies and any clinical studies and experiences With the drug
Copies of labels for the drug.
Description of scientific training and experience considered appropriate by the sponsor to qualify the investigator as a suitable expert to investigate the drug
Names and curriculum vitae of all the INVESTIGATORS
An outline of planned methodology to be adopted for the clinical trial

Discussion