Investigator’s Brochure means, in accordance with the definition in 21 C.F.R. § 312.23(a)(5), a document containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with the drug or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the drug.
Investigator’s Brochure means the compilation of the current clinical and non-clinical information on the Investigational Product relevant to the Clinical Investigation Plan and is as defined in ISO 14155:2011.
Investigator’s Brochure means a document containing the nonclinical and clinical data on the Investigational Product that are described in section C.05.005(e) of the Food and Drug Regulations (Canada);
Examples of Investigator’s Brochure in a sentence
This information is from the nirogacestat Investigator’s Brochure.
The studies are summarized in the cobimetinib Investigator’s Brochure.
Refer to the Atezolizumab Investigator’s Brochure for details on the nonclinical studies.
A characterization of the pharmacologic and PK properties of cobimetinib was performed in a series of nonclinical studies that are summarized in the cobimetinib Investigator’s Brochure.
Atezolizumab is a human immunoglobulin (Ig) G1 monoclonal antibody consisting of two heavy chains (448 amino acids) and two light chains (214 amino acids) and is produced in Chinese hamster ovary cells (Investigator’s Brochure, 2016).
More Definitions of Investigator’s Brochure
Investigator’s Brochure means a compilation of preclinical and clinical data with respect to a new investigational drug that is proposed for filing with a Regulatory Authority and used to provide information to clinical investigators and Regulatory Authorities.
Investigator’s Brochure. (or “IB”) means a compilation of the clinical and non-clinical data on the Investigational Medicinal Product or products which are relevant to the clinical trial of the product or products in human subjects.
Investigator’s Brochure means a document containing a summary of the clinical and non-clinical data on the investigational medicinal product which are relevant to the study of the product in human subjects;
Investigator’s Brochure or “IB” means, in accordance with the definition in 21 C.F.R. Part 312.23(a)(5), a document containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with the Test Article or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the Test Article.
Investigator’s Brochure means the compilation of all relevant clinical and non-clinical information and data on the relevant investigational product(s), which compilation is relevant to the study of the investigational product(s) in human subjects as provided in Section 7 of the ICH 2006 guidance document “Good Clinical Practice - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use” and any subsequent ICH guidance documents published from time to time.
Investigator’s Brochure means, in accordance with the definition in 21 C.F.R. § 312.23(a)(5), a document containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with the drug or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the drug. PHS ICT-CRADA Case Ref. No. MODEL ADOPTED 2005 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Investigator’s Brochure means a compilation of clinical and nonclinical data on an investigational product relevant to the study of the product in human subjects.