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

Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.7K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.5K
Clinical Trials01:16

Clinical Trials

10.1K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.1K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

387
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
387
Leaky Scanning02:28

Leaky Scanning

5.6K
During most eukaryotic translation processes, the small 40S ribosome subunit scans an mRNA from its 5' end until it encounters the first start AUG codon. The large 60S ribosomal subunit then joins the smaller one to initiate protein synthesis. The location of the translation initiation is largely determined by the nucleotides near the start codon as there may be multiple translation initiation sites present on the mRNA.  Marilyn Kozak discovered that the sequence RCCAUGG (where R...
5.6K
Translation01:31

Translation

17.4K
Translation is the process of synthesizing proteins from the genetic information carried by messenger RNA (mRNA). Following transcription, it constitutes the final step in the expression of genes. This process is carried out by ribosomes, complexes of protein and specialized RNA molecules. Ribosomes, transfer RNA (tRNA), and other proteins produce a chain of amino acids—the polypeptide—as the end product of translation.
Translation Produces the Building Blocks of Life
Proteins are...
17.4K

You might also read

Related Articles

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

Sort by
Same author

Injection-Site Sarcomas in Rodent Carcinogenicity Studies: Human Relevance and Labeling Implications.

Toxicologic pathology·2026
Same author

Toxicology and safety pharmacology investigations on the nervous system: 2024 industry survey.

Journal of pharmacological and toxicological methods·2025
Same author

Developmental Neurotoxicity (DNT) Studies for Chemical Safety Assessments: Basic Concepts, Experimental Strategies, and Future Directions.

Toxicologic pathology·2025
Same author

Neuromethods: Basic Techniques for Evaluating the Nervous System in Nonclinical Studies.

Toxicologic pathology·2025
Same author

2024 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: New Approach Methodologies (NAMs) for Neurotoxicity Assessment and Regulatory Perspectives.

Toxicologic pathology·2025
Same author

A Single-Molecule Liposome Assay for Membrane Permeabilization.

Angewandte Chemie (International ed. in English)·2025

Related Experiment Video

Updated: Jan 11, 2026

Xenopus laevis as a Model to Identify Translation Impairment
10:24

Xenopus laevis as a Model to Identify Translation Impairment

Published on: September 27, 2015

11.0K

Translational Challenges From Nonclinical to Clinical Program: Case Study Examples.

Deven Dandekar1, David B Hawver2, Deepa B Rao3

  • 1Department of Toxicology, ExploR&D, Eli Lilly and Company, Indianapolis, IN, USA.

International Journal of Toxicology
|November 19, 2025
PubMed
Summary

Translating nonclinical data into clinical drug development is complex. Case studies help improve skills in managing translational challenges for safer, more effective drug candidates.

Keywords:
first-in-human dosehepatic toxicitylong-acting injectablesmargin of safetymonoclonal antibodyneurotoxicitysafety study

More Related Videos

Quantitative Immunofluorescence to Measure Global Localized Translation
09:13

Quantitative Immunofluorescence to Measure Global Localized Translation

Published on: August 22, 2017

10.4K
Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
07:43

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices

Published on: July 14, 2023

2.8K

Related Experiment Videos

Last Updated: Jan 11, 2026

Xenopus laevis as a Model to Identify Translation Impairment
10:24

Xenopus laevis as a Model to Identify Translation Impairment

Published on: September 27, 2015

11.0K
Quantitative Immunofluorescence to Measure Global Localized Translation
09:13

Quantitative Immunofluorescence to Measure Global Localized Translation

Published on: August 22, 2017

10.4K
Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
07:43

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices

Published on: July 14, 2023

2.8K

Area of Science:

  • Pharmacology and Toxicology
  • Drug Development Science

Background:

  • Drug discovery and development is a lengthy, costly process (10-15 years, $1-2 billion USD).
  • Limited guidance exists on translating nonclinical data into clinical trial designs.
  • Nonclinical studies are crucial for determining safe dosage ranges for first-in-human trials.

Purpose of the Study:

  • To address the challenges in translating nonclinical findings to clinical drug development.
  • To improve skills in managing translational hurdles encountered during drug development programs.
  • To provide case study examples for enhancing the management of nonclinical to clinical transitions.

Main Methods:

  • Utilized case studies to illustrate translational challenges in drug development.
  • Focused on the integration of data from various pharmacologically relevant species.
  • Examined the importance of cross-functional collaboration among pathologists, ADME scientists, biologists, and clinicians.

Main Results:

  • Identified common reasons for drug candidate failure, including poor understanding of the translational process.
  • Highlighted the impact of effectively integrating data from different species.
  • Demonstrated how safety margins can be eroded during chronic toxicology studies.

Conclusions:

  • Effective translation of nonclinical data to clinical designs is critical for successful drug development.
  • Cross-functional collaboration is essential for navigating translational challenges.
  • Case studies offer valuable learning opportunities for improving translational strategies.