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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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,...
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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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Updated: Jun 27, 2025

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Lessons learned from a multi-data source research collaboration: The mirabegron post-authorization safety study

Stefan de Vogel1, John D Seeger2, Alejandro Arana3

  • 1Pharmacovigilance, Astellas Pharma B.V., Leiden, The Netherlands.

Pharmacoepidemiology and Drug Safety
|April 29, 2024
PubMed
Summary
This summary is machine-generated.

Conducting large, multi-data source, non-interventional, post-authorization safety studies (NI-PASS) requires careful planning. Key factors for success include collaboration, transparency, and robust methodology for reliable safety assessments.

Keywords:
learningsmulti‐data source non‐interventional post‐authorization safety studiesorganization and methodologyresearch collaboration

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Epidemiology
  • Regulatory Science

Background:

  • Multi-data source, non-interventional, post-authorization safety studies (NI-PASS) are complex undertakings for regulatory submissions.
  • Evaluating lessons learned from such large studies offers valuable insights for future research.

Purpose of the Study:

  • To discuss challenges and key factors in executing a successful post-marketing requirement (PMR)/post-authorization safety study (PASS) program.
  • To investigate cardiovascular and cancer event risks associated with mirabegron, an overactive bladder medication.

Main Methods:

  • The study involved a multi-data source, non-interventional design.
  • Methodological considerations included data source selection, patient numbers, comparator groups, and confounding factors.
  • Organizational aspects focused on collaboration, transparency, and project management.

Main Results:

  • Learnings were shared on research collaboration, scientific transparency, and organizational approaches.
  • Methods to mitigate uncertainty around delays and ensure validity of outcomes were discussed.
  • Strategies for optimizing patient numbers, comparator groups, and generalizability were presented.

Conclusions:

  • Successful execution of large PMR/PASS programs requires long-term commitment and effective coordination.
  • Extensive scientific interaction among partners, advisory boards, sponsors, and health authorities is crucial.
  • The program provided valuable learnings for the design and organization of multi-data source NI-PASS.