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[求助]
Modified-released drug product的含义
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Modified-released drug product 是否包括Extended-released drug product 和Delayed-released drug product呢？ 如果可以请提供以下出处。 |
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星海慧儿
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2楼2013-10-10 16:15:50
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5楼2013-10-11 14:45:34
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【答案】应助回帖
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BP/EP: Conventional-release dosage forms Conventional-release dosage forms are preparations showing a release of the active substance(s) which is not deliberately modified by a special formulation design and/or manufacturing method. In the case of a solid dosage form, the dissolution profile of the active substance depends essentially on its intrinsic properties. Equivalent term: immediate-release dosage form. Modified-release dosage forms Modified-release dosage forms are preparations where the rate and/or place of release of the active substance(s) is different from that of a conventional-release dosage form administered by the same route. This deliberate modification is achieved by a special formulation design and/or manufacturing method. Modified-release dosage forms include prolonged-release, delayed-release and pulsatile-release dosage forms. Prolonged-release dosage forms Prolonged-release dosage forms are modified-release dosage forms showing a slower release of the active substance(s) than that of a conventional-release dosage form administered by the same route. Prolonged-release is achieved by a special formulation design and/or manufacturing method. Equivalent term: extended-release dosage form. Delayed-release dosage forms Delayed-release dosage forms are modified-release dosage forms showing a release of the active substance(s) which is delayed. Delayed release is achieved by a special formulation design and/or manufacturing method. Delayed-release dosage forms include gastro-resistant preparations as defined in the general monographs on solid oral dosage forms. Pulsatile-release dosage forms Pulsatile-release dosage forms are modified-release dosage forms showing a sequential release of the active substance(s). Sequential release is achieved by a special formulation design and/or manufacturing method. ICH Glossary: Delayed Release: Release of a drug (or drugs) at a time other than immediately following oral administration. Extended Release: Products which are formulated to make the drug available over an extended period after administration. Immediate Release: Allows the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug. Modified Release: Dosage forms whose drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as a solution or an immediate release dosage form. Modified release solid oral dosage forms include both delayed and extended release drug products. |
6楼2013-10-11 15:00:25