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FDA 2013 Clinical Investigator Training Course: Pharmacology/Toxicology in the Investigator Brochure...
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure (Drugs): Ensuring the ...
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain a...
What is FDA Form 3454 for? Form FDA 3454, or the Financial Certification or Disclosure Statement, is...
What your organization should do and should not do during a FDA audit or inspection. For more infor...
21 CFR 312 and 314 are two separate, but related, US Food and Drug Administration (FDA) regulations ...
IND- Investigational New Drug
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Investigational new drug application approval process and IND detailed information//INDA//
INVESTIGATIONAL NEW DRUG APPLICATION AS PER FEDERAL FOOD DRUG AND COSMETIC ACT
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Gui...
regulatory affairs/Agency,IND,Types of IND, Tyes of IND application,Investigator's brochure,Cont...
In this slide share we will learn about investigation use of drugs.
21 CFR Part 50 and 54 are U.S. Food and Drug Administration (FDA) regulations for clinical trials. 2...
INVESTGATIONAL NEW DRUG APPLICATIONS
this ppt contains about 21 CFR part 312
No research without action,no action without research.
INVESTIGATIONAL NEW DRUG APPLICATION
GCP course material
intro, claasification , content and format, FDA review team, FDA approval process, etc
intoduction, classification, content and format, applications
Investigational New Drug application
drug development, IND, withdrawl of IND, exemption, IND review,
