a Department of Pharmaceutical Technology , Faculty of Pharmacy, Hacettepe University , Ankara , Turkey.
J Drug Target. 2018 Sep;26(8):633-642. doi: 10.1080/1061186X.2017.1401076. Epub 2017 Nov 23.
Developing a new drug molecule is not only time-consuming and expensive, but also mostly a failing process. However, improving bioavailability, targetability, efficacy or safety of old drugs could be more effective way to use them in clinic. For these purposes, so many strategies including individualising drug therapy, nanoparticle-based drug delivery systems, drug conjugates, therapeutic drug monitoring, stimuli-sensitive targeted therapy are investigated intensely. Depending on the desired application or targeted site, nanoparticles can be administrated as orally, locally, topically and systemically. Currently, the Food and Drug Administration and the European Medicines Agency approved nanoparticles are mostly aimed to treat cancer. Although some of these formulations were approved by Food and Drug Administration and/or European Medicines Agency to use in clinic, most of them have fell down to pass either pre-clinical or clinical trials. To have high approval rate, failure reasons need to be better understand.
开发新的药物分子不仅耗时且昂贵，而且大多是一个失败的过程。然而，提高老药物的生物利用度、靶向性、疗效或安全性可能是在临床上更有效地利用它们的方法。为此，人们研究了许多策略，包括个体化药物治疗、基于纳米粒子的药物传递系统、药物偶联物、治疗药物监测、刺激敏感靶向治疗等。根据所需的应用或靶向部位，纳米粒子可以口服、局部、局部和全身给药。目前，美国食品和药物管理局和欧洲药品管理局批准的纳米粒子主要用于治疗癌症。尽管其中一些制剂已获得美国食品和药物管理局和/或欧洲药品管理局的批准用于临床应用，但大多数制剂要么未能通过临床前试验，要么未能通过临床试验。为了获得高批准率，需要更好地了解失败的原因。
