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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
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Methods of Documentation III: PIE

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Dosage Regimens: Partial Pharmacokinetic Parameters01:01

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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
Health Information Technology and Healthcare Information System01:30

Health Information Technology and Healthcare Information System

Health Information Technology (HIT)
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

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Related Experiment Video

Updated: May 31, 2026

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

Patient experience data in formulary decision-making: Payer-reported perceptions and use.

Steven Kheloussi1, Iyar Mazar2, Magdalena Harrington2

  • 1Kheloussi Consulting, LLC, Wilkes-Barre, PA.

Journal of Managed Care & Specialty Pharmacy
|May 29, 2026
PubMed
Summary
This summary is machine-generated.

Payer decision-makers have varying understanding and use of patient experience data (PED). Barriers like subjectivity and lack of scientific validity limit PED integration into formulary decisions, necessitating further education on its value and collection methods.

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Area of Science:

  • Health Economics and Outcomes Research
  • Health Policy and Management

Background:

  • Patient experience data (PED) provide insights into patient experiences with diseases.
  • Limited data exist on payer perspectives and PED use in formulary decision-making beyond patient-reported outcomes.

Purpose of the Study:

  • To assess payer decision-maker familiarity with PED.
  • To understand payer perspectives on using PED in formulary development and benefit design.

Main Methods:

  • Conducted informal interviews with payer decision-makers to inform survey development.
  • Administered an online survey to a broader population of payer decision-makers regarding PED familiarity, use, and barriers.

Main Results:

  • Payer understanding of PED varies, with some citing non-PED sources as PED.
  • Most organizations consider PED of low to medium importance.
  • PED is infrequently incorporated into formulary decision-making due to perceived subjectivity, lack of scientific validity, and absence of standardized measures.

Conclusions:

  • Payer understanding and valuation of PED are inconsistent, hindering its meaningful use in decision-making.
  • Perceived barriers significantly impact the uptake of PED.
  • Enhanced training on the scientific merit and rigorous collection methods of PED is required.