Aug 7, 2016 07:49
7 yrs ago
2 viewers *
English term
Pre NDA-BB
English to French
Medical
Medical (general)
étude clinique/anticanc�
Overall Response Rate (ORRa (%, 95% CI) [Source: Pre NDA-BB]
Proposed translations
(French)
| 3 +1 | avant (pre) DNM biologique |
blkh
|
References
| NDA : New Drug Application - BB-IND number : Investigational New Drug |
FX Fraipont (X)
|
Proposed translations
+1
1 day 3 hrs
Selected
avant (pre) DNM biologique
données provenant d'études réalisées avant "demande de nouveau médicament" (DNM); ce médicament est "biologique" (biological based)
Peer comment(s):
| agree |
PLR TRADUZIO (X)
52 mins
|
|
merci
|
4 KudoZ points awarded for this answer.
Comment: "Merci à tous"
Reference comments
50 mins
Reference:
NDA : New Drug Application - BB-IND number : Investigational New Drug
"New Drug Application (NDA) - U.S. Food and Drug Administration
http::/www.fda.gov › ... › Types of Applications › New Drug Application (NDA)
Mar 29, 2016 - For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). .... Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* ..."
"the Department of Health and Human Services will permit importation of foreign antivenoms to be made available in the event an attack occurs, providing the institution submits the following information in triplicate to the Director, Center for Biologics Evaluation and Research (CBER), requesting an Investigational New Drug (IND and often called the "BB-IND") number:"
Pharmacology Review(s) - U.S. Food and Drug Administration
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/20287...
http::/www.fda.gov › ... › Types of Applications › New Drug Application (NDA)
Mar 29, 2016 - For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). .... Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* ..."
"the Department of Health and Human Services will permit importation of foreign antivenoms to be made available in the event an attack occurs, providing the institution submits the following information in triplicate to the Director, Center for Biologics Evaluation and Research (CBER), requesting an Investigational New Drug (IND and often called the "BB-IND") number:"
Pharmacology Review(s) - U.S. Food and Drug Administration
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/20287...
Discussion
www.itespresso.fr/press-release/takeda-dpose-au-japon-une-d...