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Related Concept Videos

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...
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...
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,...
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
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...

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Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
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Published on: February 6, 2015

New regulatory framework for cancer drug development.

Paul S Jones1, David Jones

  • 1Drug Development Office, Strategy and Research Funding, Cancer Research UK, London, UK. paul.jones@cancer.org.uk

Drug Discovery Today
|December 31, 2011
PubMed
Summary

Recent non-clinical cancer guidelines can speed up the development of new anticancer drugs. This review explores implementing these guidelines and integrating them with study designs for robust and safe clinical trials.

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Area of Science:

  • Oncology
  • Translational Medicine
  • Regulatory Science

Background:

  • Recent updates to non-clinical cancer guidelines present an opportunity to accelerate drug development.
  • Effective implementation of these guidelines is crucial for advancing novel anticancer therapies.

Purpose of the Study:

  • To review the implementation strategies for new non-clinical cancer guidelines.
  • To examine the integration of these guidelines with non-clinical and clinical study designs.
  • To ensure the development of robust and safe clinical trials for new anticancer drugs.

Main Methods:

  • Literature review of recent guideline changes.
  • Analysis of best practices in non-clinical and clinical study design.
  • Exploration of integration methodologies between preclinical and clinical phases.

Main Results:

  • Identified key strategies for guideline implementation.
  • Outlined methods for integrating non-clinical data with clinical trial protocols.
  • Highlighted the importance of robust study design for drug safety and efficacy.

Conclusions:

  • Revised non-clinical guidelines facilitate faster translation of anticancer drugs.
  • Integrating guidelines with study design enhances the quality and safety of clinical trials.
  • Strategic implementation is key to maximizing the impact of regulatory updates in oncology drug development.