Investigator's Drug Brochure

См. также в других словарях:

• Investigator'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… …   Wikipedia

• Investigational 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 …   Wikipedia

• Clinical trial — Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be… …   Wikipedia

• TGN1412 — (also known as CD28 SuperMAB) is the working name of an immunomodulatory drug which was withdrawn from development, originally intended for the treatment of B cell chronic lymphocytic leukemia (B CLL) and rheumatoid arthritis.cite web last =… …   Wikipedia

• Institutional review board — An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving… …   Wikipedia

• Psilocin — drugbox IUPAC name = 4 Hydroxy N,N dimethyl tryptamine CAS number = 520 53 6 ATC prefix = ATC suffix = PubChem = 4980 C=12 | H=16 | N=2 | O=1 molecular weight = 204.27 g/mol smiles = OC1=CC=CC2=C1C(CCN(C)C)=CN2 melting point = 173 melting high =… …   Wikipedia

• List 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 …   Wikipedia

• Clinical 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 …   Wikipedia

• Good clinical practice — is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human… …   Wikipedia

• John Holmes (actor) — Male adult bio name = John Holmes birth= birth date|1944|08|08|mf=y location= Ashville, Ohio, U.S. birthname= John Curtis Estes death= death date and age|1988|03|13|1944|08|08|mf=y primary cause of death= cardiorespiratory arrest, encephalitis,… …   Wikipedia

• Serious adverse event — A serious adverse event (SAE) in human drug trials are defined as any untowardmedical occurrence that at any dose results in #death, #is life threatening #requires inpatient hospitalization or prolongation of existing hospitalization #results in… …   Wikipedia