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Presentation prepared by Dr Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics King Fahad Medical City.
OVERVIEW
- The IB is produced and promptly updated by the sponsor.
- IB summarizes all that is known about the IP obtained from laboratory, animal, and other clinical studies. This includes pharmacology (dose, frequency, administration, safety monitoring), efficacy, and safety information.
- IB provides the information needed by the investigator to plan and conduct the study.
- IB provides IRB and other regulators background information needed to approve and monitor the study
CONTENTS OF IB - 1
- Title page: Sponsor identification, Version and date
- List of abbreviations.
- Overall summary.
- Introduction: chemical and generic names of the IP active components and rationale for further research
- Physical, chemical, and pharmaceutical properties and formulation of IP in addition to information on handling, storing, and preparation of the IP for administration.
CONTENTS OF IB - 2
- Nonclinical studies on IP: data from animal studies on pharmacological, pharmacokinetic, metabolic, and toxicological properties.
- Studies on humans: pharmacokinetics, metabolism, pharmacodynamics, dose-response, safety, efficacy, and other pharmacological aspects.
- Summary of data and guidance for the investigators: therapeutic indications, contraindications, warnings, and precautions