Online ISSN : 1347-5231
Print ISSN : 0031-6903
ISSN-L : 0031-6903
須藤 宏和
ジャーナル フリー

2019 年 139 巻 6 号 p. 891-898


The Bridging Research Accelerating Network Program of the Japan Agency for Medical Research and Development has increased academic research on nonclinical studies to acquire proof of concept for pharmaceuticals, and recently some universities with special technological knowledge have started collaborative research with pharmaceutical companies. In such joint research, companies often repeat studies conducted by academic institutions to ensure that the study data meet the reliability requirements for new drug applications (NDAs). Conducting repeated studies is costly and time consuming and delays the R&D process prior to filing NDAs. If reliable study data could be generated by academia, it would enhance the speed of drug development and promote the early launch of new drugs. This review explains aspects of research reliability which must be noted by academia, particularly with regard to studies cited in papers submitted to scientific journals or for NDAs. It also explains methods for maintaining records in experimental notebooks and how to correct records. The standards for “attributable, legible, contemporaneous, original, accurate” data, commonly referred to as the ALCOA standards, which ensure the integrity of raw data, are also introduced. In addition, the research reliability of facilities is discussed, such as how measurement equipment should be maintained and how experimental records should be stored. Ensuring the reliability of the study implementation process and the facility/equipment support process makes it possible to reconstitute studies and improve the reproducibility of the results, which is a fundamental principle of science. This review will be useful for pharmacy education in universities.

© 2019 The Pharmaceutical Society of Japan
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