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 Experiment Videos

First exposure in man: toxicological considerations.

P Spindler1, P Sjöberg, L E Knudsen

  • 1Danish Medicines Agency, Bronshøj. pesp@novo-dk

Pharmacology & Toxicology
|July 25, 2000
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

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

Sort by
Same author

The graded effect of propofol in electrophysiology-guided navigation during deep brain stimulation surgery.

NPJ Parkinson's disease·2026
Same author

Craniectomy size and decompression of the temporal base using the altered posterior question-mark incision for decompressive hemicraniectomy.

Scientific reports·2023
Same author

Evaluation of temperature sum models and timing of <i>Quassia amara</i> (Simaroubaceae) wood-chip extract to control apple sawfly (<i>Hoplocampa testudinea</i> Klug) in Sweden.

Journal of pest science·2015
Same author

Towards an alternative testing strategy for nanomaterials used in nanomedicine: lessons from NanoTEST.

Nanotoxicology·2015
Same author

A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities.

Environmental research·2015
Same author

Gender differences in cadmium and cotinine levels in prepubertal children.

Environmental research·2014

Ensuring human trial safety involves rigorous preclinical animal testing and trial design. International guidelines for these studies significantly improve the safety of early-phase clinical trials for new drugs.

Area of Science:

  • Pharmacology
  • Toxicology
  • Regulatory Science

Background:

  • Human trial safety heavily depends on preclinical animal experimentation and robust trial design.
  • International Conference on Harmonisation (ICH) and European Committee for Proprietary Medicinal Products (ECPMP) have established recommendations for preclinical safety studies.

Purpose of the Study:

  • To review and emphasize the importance of established recommendations for preclinical safety testing prior to first-in-human trials.
  • To highlight the impact of these harmonized recommendations on the safety of Phase I clinical trials.

Main Methods:

  • Review of existing international recommendations for preclinical safety studies, including local tolerance, general toxicity, genotoxicity, and reproductive toxicity.
  • Consideration of alternative testing paradigms for specific cases like low-dose pharmacokinetic screening or biotechnology-derived products lacking animal model response.

Related Experiment Videos

Main Results:

  • Preclinical testing recommendations, guided by international harmonization efforts, have demonstrably contributed to an impressive safety record in Phase I clinical trials.
  • Adherence to these guidelines ensures comprehensive characterization of drug candidates before human exposure.

Conclusions:

  • The established recommendations for preclinical testing are crucial for safeguarding volunteers and patients in early-phase human trials.
  • International harmonization of these testing protocols significantly enhances patient safety in clinical research.