Found 114 presentations matching your search
tn-ctsi
The complexity of a clinical research trial involves keeping and storing multiple essential document...
IND- Investigational New Drug
GCP is a set of guidelines for how clinical trials should be carried out. It ensures that the data...
Clinical research
intro, claasification , content and format, FDA review team, FDA approval process, etc
intoduction, classification, content and format, applications
INVESTIGATIONAL NEW DRUG APPLICATION AS PER FEDERAL FOOD DRUG AND COSMETIC ACT
An important body that overlooks the conduct of CT including safety issues
Good clinical practice ICH GCP E6
drug development, IND, withdrawl of IND, exemption, IND review,
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain a...
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, ...
4. Unit-IV:- Clinical Trials. B. Pharm. Final Year, Sem-VIII, BP804 ET: PHARMACEUTICAL REGULATORY SC...
Investigational new drug application approval process and IND detailed information//INDA//
IRB/IEC
Describing the Industry's/sponsor's/drug manufacturers' perspective of the Investigation...
clinical trail documentation
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) plays a crucial role in e...
Product Development & Technology Transfer
Institutional Review Board (IRB)
IRB/IEC serves as an independent body that reviews, evaluate, approves and decides on the scientific...
