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Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

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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...
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Clinical Trials: Overview01:11

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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...
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Drug Discovery: Overview01:26

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

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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...
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Clinical Trials01:16

Clinical Trials

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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.
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Structure-Activity Relationships and Drug Design01:28

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Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
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Updated: Dec 12, 2025

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Drug Development 101: A Primer.

Lorrene A Buckley1, Ilona Bebenek2, Paul D Cornwell1

  • 11539Eli Lilly and Co Inc, Lilly Corporate Center, Indianapolis, IN, USA.

International Journal of Toxicology
|August 9, 2020
PubMed
Summary
This summary is machine-generated.

This workshop overview covers the essential stages of drug development, from discovery and safety testing to manufacturing and regulatory submissions. It highlights challenges and best practices for bringing new drugs and devices to market.

Keywords:
CMCclinical trialdrug developmentregulatorytoxicology

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Area of Science:

  • Pharmacology and Toxicology
  • Regulatory Affairs
  • Pharmaceutical Manufacturing

Background:

  • Drug development encompasses the entire process of bringing new drugs or devices to market.
  • This involves an integrated, multidisciplinary approach including discovery, safety testing, manufacturing, clinical trials, and regulatory submissions.

Framework:

  • The "Drug Development 101" workshop provided an introductory overview of key stages.
  • Focus areas included safety assessment, chemistry, manufacturing, and controls (CMC).

Implementation:

  • Toxicologic assessment is crucial in early-phase development, guiding candidate selection and first-in-human dose determination.
  • Chemistry and manufacturing considerations address early- and late-stage development, impurity control, and quality assurance.

Implications:

  • Clinical trial development aligns with regulatory requirements and expectations.
  • Effective interaction with regulatory reviewers and best practices for Investigational New Drug (IND) and New Drug Application (NDA)/Biologic License Application (BLA) submissions are vital for successful drug approval.