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

4.8K
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...
4.8K
Drug Regulation01:25

Drug Regulation

3.0K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.0K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.7K
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...
4.7K
Pharmacovigilance01:19

Pharmacovigilance

2.0K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
2.0K
Drug Discovery: Overview01:26

Drug Discovery: Overview

10.4K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
10.4K
Clinical Trials01:16

Clinical Trials

8.5K
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...
8.5K

You might also read

Related Articles

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

Sort by
Same author

Discovery of MK-2118, a Small-Molecule Agonist of STING.

ACS medicinal chemistry letters·2026
Same author

A Randomized Controlled Trial: Evaluating the Sleep, Cancer and Rest (SleepCaRe) Trial to Improve Health-Related Quality of Life in Women Undergoing Chemotherapy for Breast Cancer.

Psycho-oncology·2026
Same author

First ADME profile of fentanyl (437-38-7) - synthetic opioid driving overdose epidemics: Comprehensive in silico studies for clinical and forensic applications.

Chemico-biological interactions·2026
Same author

Maternal Mortality in Nepal: Identifying High-Risk Groups Through Census Data.

Journal of community health·2026
Same author

WOMBAT (ANZUP 2201): A Phase 2, Single-arm Study of Bipolar Androgen Therapy in Patients with Nonmetastatic Castration-resistant Prostate Cancer with Prostate-specific Antigen Progression on Darolutamide.

European urology oncology·2026
Same author

The Lancet Commission on a citizen-centred health system for India.

Lancet (London, England)·2026

Related Experiment Video

Updated: Apr 30, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
17:28

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

10.8K

Drug safety testing paradigm, current progress and future challenges: an overview.

Varun Ahuja1, Sharad Sharma

  • 1Drug Safety Assessment, Novel Drug Discovery and Development, Lupin Limited (Research Park), 46A/47A, Nande Village, MulshiTaluka, Pune, 412 115, India.

Journal of Applied Toxicology : JAT
|April 30, 2014
PubMed
Summary

Novel approaches are essential for early toxicity screening of drug candidates to reduce pharmaceutical attrition rates. Toxicologists must adopt investigative methods, integrating various technologies to enable safer and faster drug development.

Keywords:
biomarkerdrug safetyin vitroomicstoxicity

More Related Videos

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
16:02

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation

Published on: February 10, 2023

3.0K
Assessment of Chemical Toxicity in Adult Drosophila Melanogaster
07:02

Assessment of Chemical Toxicity in Adult Drosophila Melanogaster

Published on: March 24, 2023

4.9K

Related Experiment Videos

Last Updated: Apr 30, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
17:28

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

10.8K
Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation
16:02

Demonstration of the Sequence Alignment to Predict Across Species Susceptibility Tool for Rapid Assessment of Protein Conservation

Published on: February 10, 2023

3.0K
Assessment of Chemical Toxicity in Adult Drosophila Melanogaster
07:02

Assessment of Chemical Toxicity in Adult Drosophila Melanogaster

Published on: March 24, 2023

4.9K

Area of Science:

  • Drug Discovery and Development
  • Toxicology
  • Pharmacology

Background:

  • High attrition rates in the pharmaceutical industry necessitate improved early-stage drug candidate screening.
  • Traditional toxicological approaches are insufficient for modern drug development demands.

Purpose of the Study:

  • To review advancements enabling earlier anticipation and mitigation of safety concerns in drug development.
  • To highlight the shift towards a more investigative and collaborative role for toxicologists.

Main Methods:

  • Discussion of progress in in vitro models, surrogate models, and molecular toxicology.
  • Integration of 'omics' technologies, translational safety biomarkers, stem-cell based assays, and preclinical imaging.
  • Emphasis on the evolving, interdisciplinary nature of drug safety assessment.

Main Results:

  • Emergence of translational research-centric organizations blurring traditional preclinical/clinical and efficacy/safety boundaries.
  • Development of novel approaches for predicting and managing toxicity early in the drug development pipeline.

Conclusions:

  • Toxicologists are transitioning from identifying side effects to becoming key enablers of drug development.
  • Collaboration between toxicologists, medicinal chemists, pharmacologists, and clinicians is crucial for efficient and safe drug advancement.