We print standard IB’s at size of 8.5×11 with perfect binding. Custom sizes and a variety of cover stocks are also available.
INVESTIGATOR’S BROCHURE (IB) Description:
Contains pre-clinical and clinical information related to an investigational drug. The information should be presented in a concise, simple, objective, balanced form that should be taken into account during translation.
The Investigator’s Brochure includes Title Page, which provides the Sponsor’s name, the identity of investigational product (products), an edition number and date, and the number and date of the edition it supersedes as well. The Sponsor may wish to include a Confidentiality Statement instructing to treat the IB as a confidential document. A standard Investigator’s Brochure usually includes the following sections:
- List of Abbreviations
- Summary – a brief description of significant physical, chemical and pharmaceutical properties of the investigational product, and also pharmacological, toxicological, pharmacokinetic, metabolic and therapeutic information that is relevant to the appropriate stage of clinical trial.
- Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product, all active components, pharmacological class, the rationale for performing further research with the investigational product and anticipated indications for its use. This section should provide the general approach to be followed in evaluating the investigational product.
- Physical, chemical and pharmaceutical properties and formulation of the medicinal product.
- Non-clinical studies – this section provides the data from animal studies regarding non-clinical pharmacological, pharmacokinetic, metabolic and toxicological characteristics of the investigational drug.
- Clinical studies – this section provides information on pharmacokinetics, biotransformation, safety and efficacy in humans; data on post-marketing experience if the product under investigation has been already approved for use for other indications.
- Conclusions and Guidance for the Investigator
- References (the references should be provided at the end of each section)
The Investigator’s Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.