In vitro-in vivo correlation (IVIVC) of different parameters of dosage form

Shazia Ashraf, Azka Ali, Uzma Noreen, Iqra Abdullah Jan
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Abstract

Researchers can achieve rapid drug production by discovering a mathematical link between bioavailability and dissolution testing that leads to the principle of in vitro - in vivo correlation (IVIVC). IVIVC is a mathematical model which from its in vitro output can be used to estimate in vivo action. Level A correlation is widely recognized by the regulatory agencies among all the five stages of correlation. IVIVC's suitability is demonstrated by the Biopharmaceutical Classification System (BCS). In the estimation of correlations, dissolution process design plays a central role. Other important parameters in the IVIVC analysis are the qualification of the apparatus and guidelines. During the production of IVIVC, several variables, such as first pass effect, stereochemistry, should be considered. Thus, the need for a method to compare in vitro and in vivo drug release data reliably has increased tremendously. Such an instrument shortens the time of drug growth, saves money and contributes to improved product quality. Increased IVIVC creation activity demonstrates the importance of IVIVCs to the pharmaceutical business. In the production of new pharmaceuticals, IVIVC can be used to minimize the number of human studies during the development of formulation, as the primary objective of IVIVC is to act as a replacement for bioavailability in vivo and to help bio waivers. The usage of dissolution encourages and/or validates methods and configurations for requirements. This is because in vivo importance of in vitro dissolution specifications is included in the IVIVC. Research is based on new oral dosage forms in the current scenario, where awareness of IVIVC is of vital importance. IVIVC implementations vary from drug and product production to improvements in their scale-up and post-approval. Therefore, in drug production, IVIVC should be used as an effective tool
不同剂型参数的体内外相关性(IVIVC)
研究人员可以通过发现生物利用度和溶出度测试之间的数学联系来实现药物的快速生产,从而得出体外-体内相关原理(IVIVC)。IVIVC是一种数学模型,通过其体外输出量来估计体内作用。在相关的五个阶段中,A级相关性被监管机构广泛认可。生物制药分类系统(BCS)证明了IVIVC的适用性。在相关性估计中,溶解过程设计起着核心作用。在IVIVC分析中其他重要的参数是仪器的合格性和指南。在IVIVC的生产过程中,需要考虑到初过效应、立体化学等因素。因此,需要一种可靠地比较体外和体内药物释放数据的方法已经大大增加。这种仪器缩短了药物生长的时间,节省了资金,并有助于提高产品质量。IVIVC创建活动的增加表明了IVIVC对制药业务的重要性。在新药物的生产中,IVIVC可用于在配方开发过程中最大限度地减少人体研究的数量,因为IVIVC的主要目标是作为体内生物利用度的替代品并帮助生物豁免。分解的使用鼓励和/或验证满足需求的方法和配置。这是因为体外溶出度规格在体内的重要性包含在IVIVC中。在目前的情况下,研究是基于新的口服剂型,在这种情况下,对体外免疫接种的认识至关重要。体外受精和体外受精的实施从药品和产品生产到扩大规模和批准后的改进各不相同。因此,在药物生产中,试管婴儿应该作为一种有效的工具来使用
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