Login or register (free and only takes a few minutes) to participate in this question.You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.
English to Russian translations [PRO] Medical - Medical: Pharmaceuticals | | English term or phrase: tablet strength will not be a marketed product | The validation reports which support the compound specific analytical methods used for testing entecavir film coated tablets, 0.5 mg and 1 mg are listed below in Table 3.2.P.5.3.T01 and provided on the following pages.
Analytical Research and Development methods are converted to Testing Standard methods for purposes of testing marketed product.
Method 9094 and 9973 include procedures for testing 0.1 mg tablets, which are not included in methods 95009094 and 95009973 as this *tablet strength will not be a marketed product*. The impurity reporting level of 0.05 % in method 9973 used during development and stability testing was increased to 0.10 % in method 95009973 for marketed tablet strengths, consistent with ICH guidelines. |
| Maxim PolukhinKudoZ activityQuestions: 262 ( 4 open) ( 1 without valid answers) ( 14 closed without grading) Answers: 31
| | Local time: 21:41
|
| | таблетки с таким содержанием активного вещества не представлены на рынке | Explanation: ... поскольку таблетки с таким содержанием активного вещества не представлены на рынке.
-------------------------------------------------- Note added at 5 мин (2012-02-14 06:33:10 GMT) --------------------------------------------------
Если 0,1 мг относится к весу таблеток, тогда, наверное, лучше
... таблетки этой массы не представлены... |
| Selected response from:
Igor_2006 Russian Federation Local time: 00:41
| Grading comment | 4 KudoZ points were awarded for this answer |
| |
| Discussion entries: 0 |
|---|
Automatic update in 00:
|
3 mins confidence:  peer agreement (net): +2 таблетки с таким содержанием активного вещества не представлены на рынке
Explanation: ... поскольку таблетки с таким содержанием активного вещества не представлены на рынке.
-------------------------------------------------- Note added at 5 мин (2012-02-14 06:33:10 GMT) --------------------------------------------------
Если 0,1 мг относится к весу таблеток, тогда, наверное, лучше
... таблетки этой массы не представлены...
| Igor_2006 Russian Federation Local time: 00:41 Specializes in field Native speaker of: Russian PRO pts in category: 884
|
| | | KudoZ™ translation helpThe KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases. See also: Search millions of term translations |
| |