书目名称 | Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays |
编辑 | Franz J. Hock,Michael K. Pugsley |
视频video | |
概述 | A landmark in the continuously changing world of drugs.Essential reading for scientists and managers involved in drug finding, drug development and decision making.Of use for government institutions a |
图书封面 |  |
描述 | .Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clini |
出版日期 | Reference work 2024Latest edition |
关键词 | Bioanalytical Assays; Clinical Studies; Safety Assays; Safety Pharmacokinetics; Safety Pharmacology; Safe |
版次 | 3 |
doi | https://doi.org/10.1007/978-3-031-35529-5 |
isbn_ebook | 978-3-031-35529-5 |
copyright | Springer Nature Switzerland AG 2024 |