First in Human Safety Assessment (FIHSA) Dossier

The importance of safety concerning pharmaceutical products and medical devices cannot be overemphasized. Hence, it is necessary to evaluate the response of the human body to the presence of a novel drug or device. The First in Human Safety Assessment (FIHSA) is a vital and fundamental part of clinical trials which sees an experimental drug or device making the transition from use in animals or simulations to a human body.

This course takes you on a journey through the historical evolution of the concept of safety from the technological phase to the holistic phase which takes into account technology, humans, and the organization in vie. You will be introduced to the methods of dose determination for FIHSA studies and the role of the International Conference on Harmonization (ICH) guidelines in ensuring that risks are reduced to the barest minimum.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: Historical Aspect of First Human in Safety

• First Phase of Safety – The Technology (if the technology is safe, then we will be safe)
• Second Phase of Safety – The Human Phase (if the human is safe, then we will be safe)
• Third Phase of Safety – The Organizational Phase (if the organization is safe, then we will be safe)
• Fourth Phase of Safety – The Systems or Holistic Age/Phase

Lesson 2: Successful Design for First-in-Human Safety Clinical Trials

• Preclinical Safety Testing
• Safety Monitoring

Lesson 3: First in Human Safety and Drug Development Process

• Phases of Clinical Research
• Pre-clinical studies
• Phase 0
• Phase I
• Phase II
• Phase III
• Phase IV

Lesson 4: Dose Estimation in First Human Safety

• The Objective of MSRD
• Methods of Estimating MRSD
• NOAEL Method
• The MABEL Approach for Dose Selection
• Similar Drug Comparison Method
• Pharmacokinetic Guided Method
• PK/PD Modelling Guided Approach

Lesson 5: Risk Assessment; Evaluation of Risks for First in Human Health and Safety

• The Process of Risk Assessment
• Hazard Identification
• Dose-response assessment
• Exposure assessment
• Risk estimation and characterization

Lesson 6: Role of ICH in First in Human Safety

• Objectives of ICH
• Members of ICH
• ICH Structure
• ICH Steering Committee
• ICH Coordinators
• ICH Working Group
• ICH Operation
• Safety Guidelines
• Carcinogenicity Studies (S1A-S1C
• S2 – Genotoxicity
• S3A-S3B Toxicokinetic and Pharmacokinetics

Conclusion

Glossary

Definitions

Quiz