Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Design Example: Analyzing Capacity Contours for Flood Risk Assessment01:17

Design Example: Analyzing Capacity Contours for Flood Risk Assessment

326
Flood risk assessment involves careful planning and analysis to ensure the safety of communities near water retention structures. Capacity contours are a vital tool in this process, as they illustrate the potential spread of water at specific levels in a given area. In the context of building a bund across a small valley, these contours play a critical role in evaluating the safety of nearby residential areas.In this example, the bund is intended to store stormwater in the valley. The engineers...
326
Relative Risk01:12

Relative Risk

2.2K
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
2.2K
Structural Organization of the Human Body: An Overview01:18

Structural Organization of the Human Body: An Overview

29.1K
It is convenient to consider the body's structures in terms of fundamental levels of organization that increase in complexity: subatomic particles, atoms, molecules, organelles, cells, tissues, organs, organ systems, and organisms.
To study the chemical level of organization, scientists consider the simplest building blocks of matter: subatomic particles, atoms, and molecules. All matter in the universe is composed of one or more unique pure substances called elements, familiar examples of...
29.1K
Factors Affecting the Risk of Infection01:26

Factors Affecting the Risk of Infection

13.5K
The hosts' susceptibility to infection depends on several factors. The integrity of the skin and mucous membranes helps protect the body against microbial attacks. When the skin is altered, the chance of infection, limb loss, and even death increases.
The integrity and count of the white blood cells help the body resist pathogens and fight infection. When impaired, it reduces the body's resistance to pathogens. The acidic pH levels of the gastrointestinal, genitourinary tracts, and skin...
13.5K
Structures of Solids02:22

Structures of Solids

17.8K
Solids in which the atoms, ions, or molecules are arranged in a definite repeating pattern are known as crystalline solids. Metals and ionic compounds typically form ordered, crystalline solids. A crystalline solid has a precise melting temperature because each atom or molecule of the same type is held in place with the same forces or energy. Amorphous solids or non-crystalline solids (or, sometimes, glasses) which lack an ordered internal structure and are randomly arranged. Substances that...
17.8K
Structural Isomerism02:34

Structural Isomerism

21.7K
Isomerism in Complexes
Isomers are different chemical species that have the same chemical formula. Structural isomerism of coordination compounds can be divided into two subcategories, the linkage isomers and coordination-sphere isomers.
Linkage isomers occur when the coordination compound contains a ligand that can bind to the transition metal center through two different atoms. For example, the CN− ligand can bind through the carbon atom or through the nitrogen atom. Similarly, SCN− can...
21.7K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

First-in-human study evaluating safety, pharmacokinetics, and pharmacodynamics of lorundrostat, a novel and highly selective aldosterone synthase inhibitor.

Clinical and translational science·2024
Same author

Pharmacology-Guided Rule-Based Adaptive Dose Escalation in First-in-Human Studies.

Clinical pharmacology and therapeutics·2020
Same author

Midazolam Limited Sampling Strategy With a Population Pharmacokinetic Approach to Simultaneously Estimate Cytochrome P450 (CYP) 3A Constitutive, Inhibition, and Induction/Activation Conditions in Healthy Adults.

Journal of clinical pharmacology·2019
Same author

Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies: A Moderated Forum Session.

Therapeutic innovation & regulatory science·2018
Same author

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost".

Therapeutic innovation & regulatory science·2018
Same author

A Change in Posture Significantly Affects Plasma Concentrations of Large Molecules Such as IgG Antibodies.

Journal of clinical pharmacology·2018

Related Experiment Video

Updated: Feb 5, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
19:15

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

88.0K

Structured Risk Assessment for First-in-Human Studies.

Mattheus Thijs van Iersel1, Howard E Greenberg2, Mary L Westrick3

  • 11 Early Development Services, PRA Health Sciences, Groningen, the Netherlands.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed
Summary
This summary is machine-generated.

This structured process ensures subject safety in early-phase clinical trials by carefully assessing risks for investigational products and study procedures. It prioritizes subject protection while acknowledging knowledge gaps in first-in-human studies.

Keywords:
first-in-humanphase 1risk assessmentrisk mitigationsafety

More Related Videos

Hybrid Cell Analysis System to Assess Structural and Contractile Changes of Human iPSC-Derived Cardiomyocytes for Preclinical Cardiac Risk Evaluation
08:03

Hybrid Cell Analysis System to Assess Structural and Contractile Changes of Human iPSC-Derived Cardiomyocytes for Preclinical Cardiac Risk Evaluation

Published on: October 20, 2022

2.2K
An Anatomical Study of Nerves at Risk During Minimally Invasive Hallux Valgus Surgery
15:04

An Anatomical Study of Nerves at Risk During Minimally Invasive Hallux Valgus Surgery

Published on: February 17, 2018

12.8K

Related Experiment Videos

Last Updated: Feb 5, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
19:15

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

88.0K
Hybrid Cell Analysis System to Assess Structural and Contractile Changes of Human iPSC-Derived Cardiomyocytes for Preclinical Cardiac Risk Evaluation
08:03

Hybrid Cell Analysis System to Assess Structural and Contractile Changes of Human iPSC-Derived Cardiomyocytes for Preclinical Cardiac Risk Evaluation

Published on: October 20, 2022

2.2K
An Anatomical Study of Nerves at Risk During Minimally Invasive Hallux Valgus Surgery
15:04

An Anatomical Study of Nerves at Risk During Minimally Invasive Hallux Valgus Surgery

Published on: February 17, 2018

12.8K

Area of Science:

  • Clinical Pharmacology
  • Drug Development
  • Regulatory Science

Background:

  • First-in-human (FiH) studies carry inherent risks for healthy subjects.
  • Evaluating these risks requires a systematic approach to ensure subject safety.
  • Existing risk assessment methods may lack consistency or thoroughness.

Purpose of the Study:

  • To describe a structured risk assessment and mitigation process for FiH studies.
  • To balance study risks with maximal subject protection.
  • To promote consistency and avoid omissions in risk evaluation.

Main Methods:

  • Comprehensive data review to identify potential risks for healthy subjects.
  • Structured assessment applied to investigational products, challenge agents, and procedures.
  • Emphasis on recognizing knowledge gaps and defining study scope (tolerability vs. toxicity).

Main Results:

  • Implementation of a consistent and thorough risk assessment framework.
  • Improved identification of potential risks specific to FiH studies.
  • Clearer distinction between assessing tolerability and toxicity in early trials.

Conclusions:

  • A structured risk assessment and mitigation process is crucial for safe FiH studies.
  • This process enhances subject protection by systematically evaluating all available data.
  • FiH studies should focus on tolerability, with risks carefully managed through structured assessment.