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
Drug Discovery: Overview01:26

Drug Discovery: Overview

10.8K
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...
10.8K
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
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.1K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.1K
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

171
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
171

You might also read

Related Articles

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

Sort by
Same author

Why does research integrity affect us all?

European heart journal. Cardiovascular pharmacotherapy·2026
Same author

A Polygenic Predictor of Baseline QTc is Associated With Sotalol-Induced QT Prolongation.

Circulation·2024
Same author

A Score to Predict the Clinical Usefulness of Therapeutic Drug Monitoring: Application to Oral Molecular Targeted Therapies in Cancer.

Clinical pharmacology and therapeutics·2024
Same author

Total and Unbound Pharmacokinetics of Cefiderocol in Critically Ill Patients.

Pharmaceutics·2022
Same author

Evidence-based medicine: Friend and foe.

Therapie·2022
Same author

Association of N-Acetyl Asparagine with QTc in Diabetes: A Metabolomics Study.

Biomedicines·2022
Same journal

[Prolonged fever].

La Revue du praticien·2026
Same journal

[Lower gastrointestinal bleeding].

La Revue du praticien·2026
Same journal

[Management of antiplatelet agents and oral anticoagulants in cases of gastrointestinal bleeding].

La Revue du praticien·2026
Same journal

[A history of child abuse intervention in the West].

La Revue du praticien·2026
Same journal

[Agranulocytose médicamenteuse].

La Revue du praticien·2026
Same journal

[Patient education in heart failure].

La Revue du praticien·2026
See all related articles

Related Experiment Video

Updated: Jan 5, 2026

Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
10:49

Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia

Published on: September 18, 2013

18.5K

[Early clinical drug development].

Christian Funck-Brentano1

  • 1Sorbonne université, Inserm CIC Paris-Est, AP-HP, ICAN, service de pharmacologie médicale, groupe hospitalier La Pitié-Salpêtrière, Paris, France.

La Revue Du Praticien
|October 19, 2019
PubMed
Summary
This summary is machine-generated.

Phase I drug development studies assess a new molecule's safety and effects in humans. These highly regulated trials in healthy volunteers or cancer patients determine pharmacokinetic and pharmacodynamic profiles.

Keywords:
Drug Development

More Related Videos

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

18.2K
Preclinical Drug Testing in Scalable 3D Engineered Muscle Tissues
08:07

Preclinical Drug Testing in Scalable 3D Engineered Muscle Tissues

Published on: April 7, 2023

4.2K

Related Experiment Videos

Last Updated: Jan 5, 2026

Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
10:49

Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia

Published on: September 18, 2013

18.5K
Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
07:40

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

18.2K
Preclinical Drug Testing in Scalable 3D Engineered Muscle Tissues
08:07

Preclinical Drug Testing in Scalable 3D Engineered Muscle Tissues

Published on: April 7, 2023

4.2K

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Drug Development

Background:

  • Phase I studies are the first human administration of a drug candidate.
  • They follow animal studies assessing pharmacology and toxicity.
  • These trials are crucial for initial human safety assessment.

Purpose of the Study:

  • To evaluate the safety and tolerability of a new molecule in humans.
  • To determine the pharmacokinetic and pharmacodynamic profiles of the drug.
  • To explore variability in drug response among participants.

Main Methods:

  • Administration of single and repeated doses to healthy subjects or cancer patients.
  • Conducted in authorized medical centers by trained professionals.
  • Adherence to highly regulated and standardized methodologies.

Main Results:

  • Initial assessment of pharmacological effects and toxicity in humans.
  • Characterization of how the body processes the drug (pharmacokinetics).
  • Understanding the drug's effects on the body (pharmacodynamics).

Conclusions:

  • Phase I studies are essential for establishing human safety.
  • Standardized protocols ensure reliable data collection.
  • These trials provide foundational data for further drug development.