Sentence examples for drug specifications from inspiring English sources
Sinha wants to submit experimental plans to clinical research organizations (CROs) and drug specifications to clinical manufacturing organizations (CMOs).
The stock solution of drugs were prepared according to the drug specifications and stored at −20°C.
23 Some studies used different definitions and referred drug specifications to different pharmacopoeias.
The stock solution of drugs were prepared according to the drug specifications and stored at -20°C.
Drug specifications for use in resource-limited settings may be more stringent than for developed countries as issues such as treatment durability, feasibility of manufacturing fixed-dose combination, and the possibility of being used without biological or virological monitoring are even more important.
It was also shown that the water content of the tablet was not a critical quality attribute and need not be included in the drug product specification.
Furthermore, the software predicted accurately that no special precautions are necessary to protect the product from moisture and that there is no need to control the water content of the tablets in the drug product specification.
The lower drug substance specification limit is applied to our products, (50 ppm, equivalent to 25 μg 4AP in a tablet containing 500-mg paracetamol) and the pharmacopoeial HPLC assay was not suitable at this low level due to matrix interference.
The drug substance specification is only one part of a total control strategy.
The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product.
