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  3. Medical: Pharmaceuticals

Entwicklungspräparat

English translation: product under developmnt

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Entwicklungspräparat
English translation:product under developmnt
Entered by: transatgees

01:39 Dec 28, 2010
German to English translations [PRO]
Medical - Medical: Pharmaceuticals
German term or phrase: Entwicklungspräparat
In a letter from BfArM to the managers of a clinical trial in response to their request for aproval.

"Da die reproduktionstoxologischen Untersuchungen des Entwicklungspräperats noch nicht abgeschlossen sind ......"

Thank you for your help.
transatgees
United Kingdom
Local time: 02:54
developed product
Explanation:
...would be my educated guess.




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Note added at 5 hrs (2010-12-28 06:54:10 GMT)
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product under development is also a possible translation.
Selected response from:

casper (X)
Grading comment
Thank you
3 KudoZ points were awarded for this answer



Summary of answers provided
2 +4developed product
casper (X)
3 +2investigational new drug/developmental drug/product
Marga Shaw
3 +1study product
BrigitteHilgner
3test substance
Ramey Rieger (X)


  

Answers


4 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
study product


Explanation:
Since we are talking about clinical trials.

BrigitteHilgner
Austria
Local time: 03:54
Native speaker of: Native in GermanGerman
PRO pts in category: 32

Peer comments on this answer (and responses from the answerer)
agree  British Diana
1 hr
  -> Thank you, Diana. Have a pleasant day.
neutral  Jonathan MacKerron: 'study product' might denote an already marketed product, an Enwicklungspräparat is still in the development stage
1 hr
  -> So what's your suggestion? As far as my experience goes, the term "study product" is normally not used for products already on the market.
neutral  Cetacea: Jonathan is right. Of course "study product" is used for drugs that are already on the market, just look at recent comparative studies involving e.g. statins.
2 hrs
neutral  Cilian O'Tuama: Agree with JMcK
2 days 19 hrs
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1 hr   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): +4
developed product


Explanation:
...would be my educated guess.




--------------------------------------------------
Note added at 5 hrs (2010-12-28 06:54:10 GMT)
--------------------------------------------------

product under development is also a possible translation.

Example sentence(s):
  • LEUKOCARE has announced the start of a phase II clinical trial for its proprietarily developed product designated Leukocyte Inhibition Module (LIM) to be applied in the field of cardiac surgery.

    Reference: http://shortify.com/11672
casper (X)
Native speaker of: Native in EnglishEnglish
PRO pts in category: 86
Grading comment
Thank you

Peer comments on this answer (and responses from the answerer)
agree  MMUlr: with "under development" - IMO even better: investigational drug (-> http://ctep.cancer.gov/branches/idb/ )
5 hrs
agree  Anne Schulz: with "investigational drug"
6 hrs
agree  Cilian O'Tuama: "under development" or "developmental" would be my choice.
2 days 22 hrs
agree  Harald Moelzer (medical-translator): mit Anne
3 days 13 hrs
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8 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
investigational new drug/developmental drug/product


Explanation:
investigational new drug (IND) or
developmental drug/product in a clinical trial

(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an "Investigational New Drug Application" (IND) including, in the following order:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

The clinical investigation of a drug that is not marketed requires submission of an Investigational New Drug (IND application to FDA. An IND can be issued to a company, a government agency such as NIH or NCI, or an individual investigator (sponsor-investigator). The clinical investigation of an investigational new drug may not begin until the IND goes into effect.
http://docs.google.com/viewer?a=v&q=cache:Ttp9hFkvSxYJ:healt...

Therefore, we strongly support a regulatory standard that would permit inclusion of quality published human data, in particular published cohort-controlled data and registry data, within the labeling summary of reproductive and developmental product information.
http://webcache.googleusercontent.com/search?q=cache:LZ_mqZK...

The Abigail Alliance is seeking to have legislation passed that will remove the regulatory barriers currently preventing seriously ill patients from gaining early access to developmental drugs showing efficacy in clinical trials.
http://webcache.googleusercontent.com/search?q=cache:vg-ZhJH...


Marga Shaw
United Kingdom
Local time: 02:54
Specializes in field
Native speaker of: German
PRO pts in category: 154

Peer comments on this answer (and responses from the answerer)
agree  Cetacea
11 mins
  -> Thank you, Cetacea!
agree  Cilian O'Tuama: "under development" or "developmental" would be my choice.
2 days 15 hrs
  -> Thank you, Cilian! I frequenty come across both terms.
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13 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
test substance


Explanation:
an alternative

Ramey Rieger (X)
Germany
Local time: 03:54
Native speaker of: English
PRO pts in category: 24

Peer comments on this answer (and responses from the answerer)
neutral  Cilian O'Tuama: not really, much too broad IMO
2 days 11 hrs
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