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Related Concept Videos

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 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...
Drug Discovery: Overview01:26

Drug Discovery: Overview

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...
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...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Phase zero trials: a novel approach in drug development process.

Neeraj Kumar Fuloria1, Shivkanya Fuloria, Syed Vakiloddin

  • 1Department of Pharmaceutical Quality Assurance, Anuradha College of Pharmacy, Chikhli District, Buldana, Maharashtra, India. nfuloria@gmail.com

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Summary

Phase 0 studies, utilizing microdosing, offer early insights into drug pharmacokinetics (PK) and pharmacodynamics (PD). This approach aids in lead compound selection and optimizes drug development decisions.

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Area of Science:

  • Pharmacology
  • Drug Development
  • Clinical Trials

Background:

  • Drug development is a lengthy, costly, and complex process.
  • Early-stage research is crucial for identifying viable drug candidates.
  • Traditional development pathways face challenges in predicting human efficacy and safety.

Purpose of the Study:

  • To explore the concept and contributions of Phase 0 studies in drug development.
  • To provide practical guidance for implementing Phase 0 microdosing.
  • To evaluate Phase 0's role in PK/PD profiling and lead compound selection.

Main Methods:

  • Microdosing to determine drug PK/PD relationships.
  • Balancing study design between animal models and human subjects.
  • Redefining Phase I study parameters based on Phase 0 data.

Main Results:

  • Phase 0 enables early assessment of drug behavior in humans.
  • Microdosing helps in selecting optimal lead compounds.
  • It provides a bridge between preclinical and clinical drug development.

Conclusions:

  • Phase 0 trials generate crucial human PK/PD data early in development.
  • This data significantly aids decision-making for subsequent clinical trials.
  • Phase 0 represents a valuable advancement for efficient drug design and development.