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multiple dose

English translation: multiple doses administered to the same patient

06:30 Jul 12, 2010
English language (monolingual) [PRO]
Medical - Medical (general) / RA
English term or phrase: multiple dose
A randomised, double blind, placebo-controlled, multiple dose trial ....
[does it mean that 1) different patients (treatment groups) receive different doses of study drug or 2) that the same patient receive many times the same dose?]
kgas
Poland
Local time: 05:56
Selected answer:multiple doses administered to the same patient
Explanation:
... during the course of trial, in contrast to single-dose trial (mostly for pharmacokinetic studies).



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Note added at 22 mins (2010-07-12 06:52:42 GMT)
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sorry, let me add this:
IMO there are multiple dose levels tested - e.g., in this trial:
http://clinicaltrials.gov/ct2/results?term=Study of the Effi...

See table showing the different trial arms!

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Note added at 24 mins (2010-07-12 06:54:08 GMT)
--------------------------------------------------

So your option no. 1 - different patients (usually!) in different dose groups.
Selected response from:

MMUlr
Germany
Local time: 05:56
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



SUMMARY OF ALL EXPLANATIONS PROVIDED
4 +3multiple doses administered to the same patient
MMUlr
4 +2several doses are given to each patient
Anna Herbst
Summary of reference entries provided
Support of 'multiple doses' to a trial group (multiple persons)
Demi Ebrite

Discussion entries: 2





  

Answers


17 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
multiple doses administered to the same patient


Explanation:
... during the course of trial, in contrast to single-dose trial (mostly for pharmacokinetic studies).



--------------------------------------------------
Note added at 22 mins (2010-07-12 06:52:42 GMT)
--------------------------------------------------

sorry, let me add this:
IMO there are multiple dose levels tested - e.g., in this trial:
http://clinicaltrials.gov/ct2/results?term=Study of the Effi...

See table showing the different trial arms!

--------------------------------------------------
Note added at 24 mins (2010-07-12 06:54:08 GMT)
--------------------------------------------------

So your option no. 1 - different patients (usually!) in different dose groups.

MMUlr
Germany
Local time: 05:56
Specializes in field
Native speaker of: German
PRO pts in category: 28
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Demi Ebrite
20 mins
  -> Thank you, Demi.
agree  Filippe Vasconcellos de Freitas Guimarães
4 hrs
  -> Thank you, fvasconcellos.
agree  Lynda Bogdan (X)
2 days 17 hrs
Login to enter a peer comment (or grade)

26 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
several doses are given to each patient


Explanation:
Several doses of the medication are given to each of the patients, as opposed to single dose where only one dose would be administered to the patient.

"48 subjects, divided into 6 groups and randomized in a 3:1 ratio for active treatment and placebo, received multiple oral doses of 50, 100, 150 or 200 mg PLD-118 q8h, as well as 150 or 300 mg q12h. Each volunteer received a single dose on the first day, followed by a 72 h wash out period, multiple doses for 7 days, and a single dose on the last dosing day. "


    Reference: http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102267831.h...
Anna Herbst
Australia
Local time: 13:56
Works in field
Native speaker of: Native in SwedishSwedish, Native in EnglishEnglish
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
neutral  MMUlr: also possible, but you can find different study designs / protocols, so it will definitely depend on the specific trial in question.
4 mins
  -> There would have to be more than one patient in the trial, surely...
agree  Carolyn Gille: although both answer seem correct to me, this one includes the idea that there are also 'multiple' patients (as in the source text)
5 mins
  -> Thanks Carolyn!
agree  Filippe Vasconcellos de Freitas Guimarães: I'm with Carolyn. Multiple patients (otherwise it's not a trial!) given various doses of the same drug, e.g. 20, 40, 60, 80, 100 mg. A common design for tolerability trials.
4 hrs
  -> Thanks, that's what I thought as well.
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Reference comments


1 hr peer agreement (net): +1
Reference: Support of 'multiple doses' to a trial group (multiple persons)

Reference information:
The study sited in the first reference URL is a clear example of a "randomised, double blind, placebo-controlled, multiple dose trial" performed by Gilead Sciences.

The second URL provides a list of many trials found using the search words: randomised, double blind, placebo-controlled, multiple dose trial on the Clinicaltrials.gov site, a service of the U.S. National Institutes of Health.


    Reference: http://clinicaltrials.gov/ct2/show/NCT00999531
    Reference: http://clinicaltrials.gov/ct2/results?term=randomised%2C+dou...
Demi Ebrite
United States
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 36

Peer comments on this reference comment (and responses from the reference poster)
agree  Filippe Vasconcellos de Freitas Guimarães: That study arms table certainly puts the "multiple dose" in "multiple-dose trial" :)
4 hrs
  -> That it does! Thank you, fvasconcellos.
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