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Subject: multiple strengths pharm. В сертификате анализа указано, что для "multiple strengths" используеются одинаковые container/closure.Подскажите, пожалуйста, multiple strengths? - различные дозировки? |
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нннуу поскоку .... Container closure system = The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system. и поскоку The differences in the samples for the same drug product should be identified as, for example, covering different batches, different strengths, different sizes of the same container closure system, and, possibly in some cases, different container closure systems. а также Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). то, скорее всего strength - это масса лекарственного препарата, т.е. дозировка... |
| различные дозировки |
| спасибо! |
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