investigational product
1Investigational product — An investigational product is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in… …
2Investigational new drug — The United States Food and Drug Administration s investigational new drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a …
3List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T …
4Clinical site — A clinical site is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to. The foundations for these regulations are …
5Therapeutic Products Directorate — (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. Prior to being given market authorization, a manufacturer must …
6InSilico modeling — InSilico modelling is a form of computer based modelling whose technologies are applied in: * drug target identification or drug discovery processes e.g. by provision models for cancer or pathogens * whole cell analysis of prokaryotic and… …
7Open access (disambiguation) — Open access usually refers to Open access in publishing, access to material (mainly scholarly publications) via the Internet in such a way that the material is free for all to read, and to use (or reuse) to various extents and the related… …
8Investigator's brochure — The Investigator s Brochure (IB) is a basic document which is required in a clinical trial of a new drug (that is, one not yet approved by regulatory authorities for sale), together with the clinical trial protocol. The IB contains both clinical… …
9Лекарственное средство для клинических исследований — (investigational product): дозированная лекарственная форма активной фармацевтической субстанции или плацебо, исследуемая или используемая в качестве препарата сравнения при проведении клинического исследования, включая уже зарегистрированные… …
10pharmaceutical industry — Producers of pharmaceuticals, substances used in the diagnosis, treatment, and prevention of disease and the modification of organic functions. The earliest records of medicinal plants and minerals are those of the ancient Chinese, Hindu, and… …
