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

Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Clinical Trials01:16

Clinical Trials

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

Drug Administration and Therapy Phases: Overview

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...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Phase I Oxidative Reactions: Overview01:19

Phase I Oxidative Reactions: Overview

Phase I biotransformation, or functionalization, is a crucial chemical process that converts drugs and other xenobiotics into more water-soluble forms, facilitating expulsion from the body. It involves oxidative, reductive, and hydrolytic reactions that add or unveil polar functional groups on lipophilic substrates. Key players in phase I reactions are the mixed-function oxidases. Situated in liver cell microsomes, these enzymes predominantly carry out drug metabolism. They require molecular...

You might also read

Related Articles

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

Sort by
Same author

[Retracted] Antitumor activity of NRC‑AN‑019 in a pre‑clinical breast cancer model.

International journal of oncology·2026
Same author

Efficacy of Standardized Extract of <i>Bacopa monnieri</i> (Bacognize®) on Cognitive Functions of Medical Students: A Six-Week, Randomized Placebo-Controlled Trial.

Evidence-based complementary and alternative medicine : eCAM·2016
Same author

A randomized, double blind, placebo controlled, cross over study to evaluate the analgesic activity of Boswellia serrata in healthy volunteers using mechanical pain model.

Indian journal of pharmacology·2014
Same author

Bioequivalence and tolerability study of two brands of clopidogrel tablets, using inhibition of platelet aggregation and pharmacodynamic measures.

Current therapeutic research, clinical and experimental·2014
Same author

Limonoids from the leaves of Soymida febrifuga and their insect antifeedant activities.

Bioorganic & medicinal chemistry letters·2014
Same author

Human experimental pain models: A review of standardized methods in drug development.

Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences·2013

Related Experiment Video

Updated: Jun 4, 2026

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning
09:22

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning

Published on: June 22, 2015

Phase 0 - Microdosing strategy in clinical trials.

P Usha Rani1, M U R Naidu

  • 1Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India.

Indian Journal of Pharmacology
|February 1, 2011
PubMed
Summary
This summary is machine-generated.

Microdosing uses tiny drug doses to understand pharmacokinetics in humans, complementing animal studies. This approach could redefine early clinical research and drug development.

Keywords:
Drug discovery and developmentmicrodosingphase 0

More Related Videos

Mass Spectrometry and Luminogenic-based Approaches to Characterize Phase I Metabolic Competency of In Vitro Cell Cultures
10:44

Mass Spectrometry and Luminogenic-based Approaches to Characterize Phase I Metabolic Competency of In Vitro Cell Cultures

Published on: March 28, 2017

Related Experiment Videos

Last Updated: Jun 4, 2026

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning
09:22

A Method for Remotely Silencing Neural Activity in Rodents During Discrete Phases of Learning

Published on: June 22, 2015

Mass Spectrometry and Luminogenic-based Approaches to Characterize Phase I Metabolic Competency of In Vitro Cell Cultures
10:44

Mass Spectrometry and Luminogenic-based Approaches to Characterize Phase I Metabolic Competency of In Vitro Cell Cultures

Published on: March 28, 2017

Area of Science:

  • Pharmacokinetics
  • Drug Development
  • Clinical Research

Background:

  • Drug development is lengthy, costly, and faces high attrition rates.
  • The FDA's 'Critical Path' initiative highlighted a gap between scientific progress and drug development.
  • Microdosing emerged as a strategy to address challenges in the drug development paradigm.

Purpose of the Study:

  • To introduce and define the concept of microdosing in drug development.
  • To explore microdosing as a viable tool to optimize the drug development process.
  • To assess the potential of microdosing to complement existing preclinical and clinical research methods.

Main Methods:

  • Utilizing extremely low, non-pharmacologically active doses of investigational drugs.
  • Administering these microdoses to human subjects.
  • Analyzing the pharmacokinetic profile of the drug in the human body.

Main Results:

  • Microdosing provides a method to determine drug pharmacokinetic profiles early in human subjects.
  • The strategy offers a potential alternative or complement to traditional animal-to-human scaling.
  • It can inform the design and execution of Phase I clinical trials.

Conclusions:

  • Microdosing represents a novel and viable strategy within the drug development 'toolbox'.
  • This approach has the potential to refine Phase I clinical research and improve drug development efficiency.
  • Advancements in technology for Phase 0 studies will likely expand the application of human microdosing in future drug development pipelines.