In drug development, the Searcher Brochure ( IB ) is a comprehensive document that summarizes the body of information about the product being studied ("IP" or "study drug") obtained during the drug trial. IB is a very important document throughout the drug development process and is updated with new information available. The purpose of IB is to collect data relevant to IP studies in human subjects collected during preclinical and other clinical trials.
IB is intended to provide investigators with the insights necessary for the management of learning behavior and study of the subject during clinical trials. IB may introduce key aspects and safety measures of clinical trial protocols, such as:
- Dose (from study drug)
- Frequency of dosing interval
- Administrative methods
- Security monitoring procedures
The IB contains the "Data Summary and Guidance for Investigators" section, whose primary purpose is to "provide a clear understanding to the researcher about possible risks and adverse reactions, and specific tests, observations, and precautions that may be required for clinical trials. should be based on the physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information available on the product under study The guidance should also be provided to clinical investigators about the recognition and treatment of possible overdose and adverse drug reactions based on previous human experience and on the pharmacology of the product under study ".
The sponsor is responsible for keeping the information in IB current. The IB should be reviewed annually and should be updated when new and important information is available, such as when the drug receives marketing approval and may be prescribed for commercial use.
Due to the importance of IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP) , US. The Food and Drug Administration has written a code of rules and guidelines for writing an IB, and the International Conference on Harmonization (ICH) has prepared detailed guidelines for IB writing in the European Union (< b> European Union ), Japan, and the United States ( US ).
Video Investigator's brochure
Guide document
As part of its guidance on Good Clinical Practice ( GCP ), the International Conference on Harmonization (ICH ) has prepared detailed guidelines for the contents of IB in the European Union ( EU ), Japan, and the United States ( US ). [1]
If many clinical trials have been completed, the tables that summarize the findings in various studies can be very useful for showing results in, for example, different patient populations or different indications.
- Federal Regulatory Code, Title 21, Section 312, New Drug Application of Investigation [2]
- Federal Regulatory Code, Title 21, Section 201.56 (and Section 201.57) [3]
- CDER Guidance for Industry. Adverse Part of Labeling for Prescription Drugs and Biological Products - Content and Formats. [4]
- CDER Guidance for Industry. Clinical Study Section Giving Labels for Prescription Drugs and Biological Products - Content and Formats. [5]
- CDER Guidance for Industry. Estimating Maximum Safe Initial Dose in Early Clinical Trial for Therapy in Adult Healthy Volunteers. [6]
Maps Investigator's brochure
See also
- Directive 2001/20/EC (Europe)
- Directive 2005/28/EC (Europe)
- Clinical trials
References
- International Conference on Harmonization ( ICH ) Topic E6-Guidelines for Good Clinical Practice [7]
- gcp investigative brochure
Source of the article : Wikipedia
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