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dose expansion phase

English translation: vde. below

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:dose expansion phase
Selected answer:vde. below
Entered by: Rolf Keiser

09:39 Aug 28, 2009
English language (monolingual) [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: dose expansion phase
There will be 2 parts to this study – part A (dose escalation phase) and part B (dose expansion phase) of the study.
[what does 'expansion' refer to?]
kgas
Poland
Local time: 13:19
vde. below
Explanation:
according to my understanding
escalation could mean the increase of the individual dosage while
expansion could imply extending the dosage to a greater number of subjects (e.g. test patients)

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Note added at 30 days (2009-09-28 08:34:04 GMT) Post-grading
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Thanks, jmarcin2
Selected response from:

Rolf Keiser
Switzerland
Local time: 13:19
Grading comment
Thank you!
4 KudoZ points were awarded for this answer



SUMMARY OF ALL EXPLANATIONS PROVIDED
3 +1vde. below
Rolf Keiser
Summary of reference entries provided
This report shows the details
MMUlr

  

Answers


55 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
vde. below


Explanation:
according to my understanding
escalation could mean the increase of the individual dosage while
expansion could imply extending the dosage to a greater number of subjects (e.g. test patients)

--------------------------------------------------
Note added at 30 days (2009-09-28 08:34:04 GMT) Post-grading
--------------------------------------------------

Thanks, jmarcin2

Rolf Keiser
Switzerland
Local time: 13:19
Native speaker of: Native in EnglishEnglish, Native in GermanGerman
PRO pts in category: 4
Grading comment
Thank you!

Peer comments on this answer (and responses from the answerer)
agree  Yasutomo Kanazawa
20 mins
  -> Thanks, Yasutomo
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Reference comments


4 hrs
Reference: This report shows the details

Reference information:
Pls. refer to the study protocoll for both phases, dose escalation and dose expansion.

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA...

The point is that in the second phase additional 10 subjects (in this study example) will receive the highest dose (at completion of dose escalation phase) and stay on that dose.

HTH

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Note added at 4 hrs (2009-08-28 13:42:54 GMT)
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sorry: *protocol* (not protocoll)

MMUlr
Germany
Specializes in field
Native speaker of: German
PRO pts in category: 12
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