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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...
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...
Drug Regulation01:25

Drug Regulation

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...
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...
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...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Promoting, improving and accelerating the drug development and approval processes.

A I Graul

    Drug News & Perspectives
    |February 28, 2008
    PubMed
    Summary
    This summary is machine-generated.

    Regulatory agencies facilitate new drug development through programs like microdosing (Phase 0), orphan drug initiatives, and FDA

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    Area of Science:

    • Drug development and regulatory science.
    • Clinical trial design and innovation.
    • Pharmaceutical policy and rare disease treatment.

    Background:

    • New medicines require streamlined development pathways.
    • Regulatory agencies aim to accelerate drug approval.
    • Addressing unmet medical needs is a key objective.

    Purpose of the Study:

    • To review three key drug development programs.
    • To highlight new developments in 2007.
    • To explain regulatory initiatives for new medicines.

    Main Methods:

    • Review of regulatory agency programs.
    • Analysis of microdosing (Phase 0) clinical trials.
    • Examination of orphan drug and fast track development programs.

    Main Results:

    • Introduction of microdosing (Phase 0) in the U.S. and Europe.
    • Establishment of orphan drug programs globally.
    • FDA's fast track program to expedite review for serious diseases.

    Conclusions:

    • Regulatory programs significantly impact new medicine development.
    • Microdosing, orphan drugs, and fast track offer distinct benefits.
    • Continued innovation in regulatory pathways is crucial for public health.