Named after the silica, main component of computer parts. In silico technologies encompass a large number of approaches that may assist in the prediction of toxicity and fate of new and existing chemicals.
Latest Glossary Definitions
A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.
The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference o
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by
Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.