Glossary entry (derived from question below)
английский term or phrase:
to qualify the 500 mg strength for a bio-waiver
русский translation:
для освобождения дозировки 500 мг от обязательного испытания на биоэквивалентность
Added to glossary by
Anton Konashenok
Jun 1, 2013 12:36
11 yrs ago
3 viewers *
английский term
PHARMACY - LIFE SCIENCES
Native in: русский
Works in: английский => русский, русский => английский
to qualify the 500 mg strength for a bio-waiver
английский => русский
Медицина
Медицина: Фармацевтика
A tablet dosage form to be considered pharmaceutically equivalent to the reference listed drug.
Rapidly dissolved in acidic medium.
Meeting general physical and chemical specifications for a solid dosage form.
Meeting ICH and USP criteria of identity, safety, stability, content uniformity, purity and potency.
The two tablet strengths (500 mg and 1000 mg) should be proportional *to qualify the 500 mg strength for a bio-waiver*.
Rapidly dissolved in acidic medium.
Meeting general physical and chemical specifications for a solid dosage form.
Meeting ICH and USP criteria of identity, safety, stability, content uniformity, purity and potency.
The two tablet strengths (500 mg and 1000 mg) should be proportional *to qualify the 500 mg strength for a bio-waiver*.
Proposed translations
(русский)
| 4 +1 | для освобождения дозировки 500 мг от обязательного испытания на биоэквивалентность |
Anton Konashenok
|
Change log
Jun 20, 2013 07:21: Anton Konashenok Created KOG entry
Proposed translations
+1
9 мин
Anton Konashenok
Чехия
Чехия
Native in английский
&
русский
Specializes in field
Чехия
Competing on quality, not on price
Native in: русский 
, английский
Works in: французский => английский, чешский => английский, датский => английский, and 10 more.
Related KudoZ points
:
143
Selected
для освобождения дозировки 500 мг от обязательного испытания на биоэквивалентность
(в противном случае испытываться должны были бы обе дозировки)
4 KudoZ points awarded for this answer.
Comment: "Спасибо"
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