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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.
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Drug Regulation01:25

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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...
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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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In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
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FDA Approved Drugs: Changes to Approved Drugs01:26

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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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Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

Tanja Peters1, Nigel Soanes2, Maya Abbas3

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Pharmaceutical legislation mandates pharmacovigilance systems (PV systems) for medicine safety. The European Federation of Pharmaceutical Industries and Associations developed recommendations to harmonize PV system development globally.

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Area of Science:

  • Pharmacovigilance
  • Pharmaceutical Regulation
  • Global Health Policy

Background:

  • Pharmaceutical legislation establishes legal frameworks for safe medicine use, requiring National Regulatory Authorities (NRAs) to implement pharmacovigilance (PV) systems.
  • Diverse global PV system requirements, including those outside ICH guidelines, create complexity for stakeholders like Marketing Authorisation Holders (MAHs).
  • Experience with varied PV systems, from suboptimal to resource-optimized, highlights the need for standardized approaches.

Purpose of the Study:

  • To present consensus recommendations for developing and implementing key pharmacovigilance system components.
  • To support countries, particularly those with limited resources, in establishing or enhancing their PV systems.
  • To align PV system development with harmonized international standards.

Main Methods:

  • Review of existing pharmaceutical legislation and pharmacovigilance system requirements globally.
  • Analysis of diverse PV system frameworks, referencing tools like the WHO Global Benchmarking Tool.
  • Development of consensus recommendations by the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG).

Main Results:

  • The EFPIA International Pharmacovigilance Group (IPVG) developed consensus recommendations for PV system development.
  • These recommendations are consistent with harmonized standards for key PV system components.
  • The approach facilitates step-wise implementation, adaptable to varying resource levels.

Conclusions:

  • Harmonized pharmacovigilance system development is crucial for ensuring global medicine safety.
  • The EFPIA IPVG recommendations offer a practical framework for countries to build or improve their PV systems.
  • Standardized, resource-aware PV system implementation benefits both regulatory compliance and patient safety.