Mehrotra Sonal, Salwa A, Kumar Lalit
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Udupi 576 104, Karnataka, India.
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Udupi 576 104, Karnataka, India; Department of Pharmaceutics, Delhi Institute of Pharmaceutical Sciences & Research, Delhi Pharmaceutical Sciences & Research University, Pushp Vihar, MB Road, Sect. III, New Delhi 110017, India.
Crit Rev Ther Drug Carrier Syst. 2023;40(3):1-46. doi: 10.1615/CritRevTherDrugCarrierSyst.2022042927.
Quality by design (QbD) has recently fascinated researchers for utilizing it in various arenas of pharma trends. By overcoming the conventional process, QbD prevents the risk of errors caused by the 'guess and by god approach'. This framework fosters profound knowledge of product and process quality by implying sound science and risk assessment strategies. The virtue of QbD leads to the collaborative contribution to pharmaceutical industrialists and satisfies the regulatory bodies. Additionally, leading to rapid production, saves time and expenditure, tremendous versatility, provides immense knowledge, improves robustness, higher consistency, reduces user's dilemma, decreases certainty of failure, declining inter-batch variation in pharmaceutical development. In this ever-increasing continuous production world, regulatory organizations such as the U.S. Food & Drug Administration and the International Conference on Harmonization recommend Q8 to Q14 guidelines in order to obtain the desired quality product. This review extensively discusses on various approaches of QbD for the pharmaceutical development of nano-carrier drug delivery systems. Additionally, QbD's applications in process and analytical method development techniques are documented.
设计质量（QbD）最近吸引了研究人员，使其在制药趋势的各个领域得到应用。通过克服传统工艺，QbD可防止“凭猜测和靠运气的方法”所导致的错误风险。该框架通过运用合理的科学和风险评估策略，促进对产品和工艺质量的深入了解。QbD的优点在于为制药行业人士做出了协同贡献，并满足了监管机构的要求。此外，它还能实现快速生产，节省时间和成本，具有极大的通用性，提供丰富的知识，提高稳健性，增强一致性，减少用户的困扰，降低失败的确定性，减少药物研发过程中的批次间差异。在这个持续生产不断增加的世界里，美国食品药品监督管理局和国际协调会议等监管机构推荐Q8至Q14指南，以获得所需质量的产品。本综述广泛讨论了用于纳米载体药物递送系统药物研发的QbD的各种方法。此外，还记录了QbD在工艺和分析方法开发技术中的应用。
