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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.
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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
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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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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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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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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
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Using 'big data' to validate claims made in the pharmaceutical approval process.

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  • 1a Healthcore Inc. , Wilmington , DE USA.

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Big Data in healthcare enables validation of medication and device claims. Analyzing large patient datasets supports formulary submissions and therapeutic reviews.

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Area of Science:

  • Health Informatics
  • Data Science in Healthcare
  • Pharmacoeconomics

Background:

  • Healthcare generates vast amounts of patient data from sources like electronic medical records and insurance claims.
  • This data is crucial for regulatory review and assessing the performance of medications and medical devices.

Purpose of the Study:

  • To explore the role of Big Data in validating healthcare claims for medications and devices.
  • To determine how Big Data can support formulary submissions and therapeutic class reviews.

Main Methods:

  • Utilizing Big Data for retrospective and prospective research on claims validation.
  • Analyzing health insurance records to assess therapy effectiveness and identify treatment gaps.
  • Identifying key variables for direct or proxy validation of manufacturer claims.

Main Results:

  • Big Data facilitates the expression of comparative benefits and costs in measurable terms for formulary committees.
  • It enables the identification of target populations for observational studies and validation protocols.
  • Passive and active research methods using Big Data can test manufacturer claims against real-world evidence.

Conclusions:

  • Big Data analysis is essential for robust healthcare claims validation.
  • It provides valuable insights for formulary submissions, regulatory processes, and ongoing therapeutic reviews.
  • Understanding Big Data's strengths and weaknesses is key to leveraging its value in the pharmaceutical industry.