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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...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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...
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...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Published on: December 11, 2016

[Post-authorization research, registries, and drug development].

Francesca Patarnello1, Giuseppe Recchia

  • 1GlaxoSmithKline, Verona. francesca.patarnello@gsk.com

Recenti Progressi in Medicina
|June 27, 2013
PubMed
Summary
This summary is machine-generated.

Addressing drug development challenges requires integrating evidence for registration, reimbursement, and post-authorization research. A "second generation" health technology assessment (HTA) approach can enhance drug safety and effectiveness profiles.

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Area of Science:

  • Pharmaceutical R&D
  • Health Economics
  • Clinical Pharmacology

Context:

  • Drug development faces challenges including R&D productivity, immature benefit-risk profiles, and economic sustainability of high-cost drugs.
  • Regulators, payers, and providers are seeking solutions to improve drug evaluation and access to innovation.
  • Existing systems struggle to link evidence requirements across registration, reimbursement, and post-authorization research.

Purpose:

  • To explore the potential for a continuum of evidence requirements from drug registration to post-authorization research.
  • To identify strategies for improving the knowledge profile of new drugs and mitigating clinical and economic risks.
  • To propose a "second generation" health technology assessment (HTA) approach for more integrated evidence generation.

Summary:

  • The Italian "New Drugs AIFA Registries" offer a model for managing new drugs, incorporating risk-sharing schemes.
  • This approach highlights the need for better governance in coverage with evidence, monitoring, and comparative effectiveness research.
  • A key advancement involves integrating diverse data sources and stakeholders within a comprehensive HTA framework.

Impact:

  • Enhancing the evidence profile of new drugs to facilitate patient access to innovation.
  • Reducing clinical and economic risks associated with incomplete drug safety and effectiveness data.
  • Promoting best research practices in all evidence generation approaches for robust drug evaluation.