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palier de doses

English translation: dosage level

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:palier de doses
English translation:dosage level
Entered by: Ysabel812

09:38 Jul 11, 2008
French to English translations [PRO]
Medical - Medical: Pharmaceuticals / Essai clinique/ Clinical trial
French term or phrase: palier de doses
One of the aspects of a clinical trial which can be modified, leading to the submission of an "amendment to clinical trial" to Afssaps.

The heading is "Traitement(s) administré(s)

c) Modification des modalités d'administration des médicaments
d) Modification de la dose
e) Ajout de paliers de doses
f) Modification de la durée d'exposition au ME

Thanks!

**I'd like to ask only Native English speakers to reply to this question**
Ysabel812
dosage level
Explanation:
If researchers want to add more dosage levels to a protocol, they'll need re-approval.

"In this multicenter trial, physicians will evaluate multiple dosage levels of sodium phenylbutyrate to determine the maximum tolerated dose (MTD), or the highest dose that can be safely given to children with SMA type I."
http://clinicaltrials.gov/ct2/show?term=Motor Neuron Diseas...

"Different dosage levels will also be explored at this stage to determine the optimum dose."
http://www.crucell.com/R_and_D-Clinical_Trials
Selected response from:

aricb
Local time: 13:23
Grading comment
Ok thanks so much for your help here!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +4dosage level
aricb
4 +1dose escalation levels
Drmanu49


  

Answers


23 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +4
dosage level


Explanation:
If researchers want to add more dosage levels to a protocol, they'll need re-approval.

"In this multicenter trial, physicians will evaluate multiple dosage levels of sodium phenylbutyrate to determine the maximum tolerated dose (MTD), or the highest dose that can be safely given to children with SMA type I."
http://clinicaltrials.gov/ct2/show?term=Motor Neuron Diseas...

"Different dosage levels will also be explored at this stage to determine the optimum dose."
http://www.crucell.com/R_and_D-Clinical_Trials


aricb
Local time: 13:23
Native speaker of: Native in EnglishEnglish
PRO pts in category: 4
Grading comment
Ok thanks so much for your help here!

Peer comments on this answer (and responses from the answerer)
agree  transdoctor (X): or dosage steps
20 mins
  -> Thank you
agree  :::::::::: (X)
47 mins
  -> Thank you
agree  sktrans
1 hr
  -> Thanks, sktrans
agree  mdcdc
5 hrs
  -> Thanks, mdcdc
Login to enter a peer comment (or grade)

43 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
dose escalation levels


Explanation:
This Phase I dose-escalation study was designed to evaluate the safety and tolerability of atrasentan (ABT-627), estimate the MTD, and characterize the PK ...
clincancerres.aacrjournals.org/cgi/content/full/9/8/2965 -

At least three patients were treated and evaluated for dose-limiting toxicities at each dose level prior to dose escalation. Pharmacokinetic samples were ...
www.asco.org/.../Abstracts?&vmview=abst_detail_view&confID=... - 38k -

Drmanu49
France
Local time: 21:23
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1131

Peer comments on this answer (and responses from the answerer)
agree  Jean-Louis S.
4 hrs
  -> Thank you.
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