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Zulassungsphase

English translation: approval process

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19:45 Aug 5, 2006
German to English translations [PRO]
Bus/Financial - Marketing / Market Research
German term or phrase: Zulassungsphase
"Zur Zeit befindet sich XYZ noch in der Zulassungsphase, ist aber schon startklar für die Markteinführung."

This is from an article about a new pharmaceutical product. Could anyone explain what "Zulassungsphase" means? I thought it meant that it was still being reviewed for approval, but it says in the same sentence that it has already been given the green light. Or am I missing something obvious here?

Many thanks


Ian
xxxIanW
Local time: 13:21
English translation:approval process
Explanation:
P6
http://wertpapier-analysten.de/filepools/show_file.php?pool=...
Selected response from:

Lancashireman
United Kingdom
Local time: 12:21
Grading comment
OK, thanks all round
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +6approval processLancashireman
3 +4approval phase
Trudy Peters
3admittance (certification) process
Raghunathan
2registration phase
Jonathan MacKerron


Discussion entries: 2





  

Answers


57 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +6
approval process


Explanation:
P6
http://wertpapier-analysten.de/filepools/show_file.php?pool=...

Lancashireman
United Kingdom
Local time: 12:21
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 232
Grading comment
OK, thanks all round

Peer comments on this answer (and responses from the answerer)
agree  Armin Prediger
12 mins

agree  Teresa Reinhardt: it just means that they've got their marketing concept etc. done; the only thing that's missing is the official approval
30 mins
  -> Thanks, Teresa. Your added comment effectively addresses the underlying question here.

agree  jokerman: yes, "approval process" or "approval phase" - both is fine
37 mins
  -> Thanks, jokerman. I agree with your comment above that the actual problem here lies with the interpretation of ‘startklar’.

agree  BirgitBerlin
45 mins

agree  xxxFrancis Lee: Yes, "process" rather than "phase". And as it could be ambiguous, better to insert "regulatory". In the US: "FDA approval process"
12 hrs

agree  MMUlr: maybe even more commonly used - see http://www.barrlabs.com/proprietary/approval.php
13 hrs
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2 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5
registration phase


Explanation:
might be more appropriate for your specific case

Jonathan MacKerron
Native speaker of: Native in EnglishEnglish
PRO pts in category: 92
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1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +4
approval phase


Explanation:
From the following excerpt, it looks like when the drug enters the final FDA approval phase, it has a 90% chance of success. So maybe they're assuming it will be marketed. But you're right, the sentence doesn't make sense as it stands.

As the drug moves through the development process, the risk decreases with each major milestone. The Pharmaceutical Research and Manufacturers of America reported in 2003 that drugs entering Phase I clinical trials have a 15% probability of becoming a marketable product. For those in Phase II, the odds of success rise to 30%, and for Phase III, they climb to 60%. Once clinical trials are complete and the drug enters the final FDA approval phase, it has a 90% chance of success. These improvements in the odds of success translate directly into stock value.


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Note added at 1 hr (2006-08-05 21:16:57 GMT)
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www.investopedia.com/articles/stocks/06/BiotechValuation.as...

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Note added at 4 hrs (2006-08-06 00:26:08 GMT)
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Jokerman's comment makes sense. It means the drug is ready to go (startklar) as soon as it receives approval.

Trudy Peters
United States
Local time: 07:21
Works in field
Native speaker of: Native in GermanGerman, Native in EnglishEnglish
PRO pts in category: 50

Peer comments on this answer (and responses from the answerer)
agree  jokerman: yes, "approval phase" is fine, as well
4 mins

agree  Teresa Reinhardt
1 hr

agree  Carlos Almeida: agree
1 hr

agree  MMUlr: with approval phase, see http://www.novonordisk.com/science/our_core_comp/pharmaceuti... and http://www.southcentre.org/publications/protection/protectio... (latter on the term 'registration')
12 hrs
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7 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
admittance (certification) process


Explanation:
qualification procedure. See this link for "qualification procedure"

http://www.enpirion.com/qualificationprocedures.asp.

It is ready for introduction into the market is fine. What I understand by "approval phase / process" is that the product is in final stages for being cleared. Do you really infer this from the text? I thought I can go one step below, i.e. "prior to the approval stage", i.e. the pharmaceutical product is undergoing the process of testing (qualification) for meeting the eligibility criteria.



Raghunathan
Local time: 16:51
Works in field
Native speaker of: Tamil
PRO pts in category: 2
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