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Related Concept Videos

Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

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...
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).
Analysis of Population Pharmacokinetic Data01:12

Analysis of Population Pharmacokinetic Data

Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...
Pharmacokinetic Models: Comparison and Selection Criterion01:26

Pharmacokinetic Models: Comparison and Selection Criterion

Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Drug Dosing: Geriatric Patients01:15

Drug Dosing: Geriatric Patients

Elderly individuals encompass a diverse population with varying degrees of age-related physiological changes. Defining the elderly presents challenges, as the geriatric population is often arbitrarily categorized as individuals older than 65. However, many individuals in this group lead active and healthy lives, with an increasing number surpassing 85 years and falling into the older elderly category. Physiological changes associated with aging impact performance capacity and homeostatic...

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Related Experiment Videos

Korean guidelines for pharmacoeconomic evaluation (second and updated version) : consensus and compromise.

Seungjin Bae1, Soook Lee, Eun Young Bae

  • 1Health Insurance Review and Assessment Service, Research and Development Center, 1451-34, Seocho-3dong, Seocho-gu, Seoul, 137-926, The Republic of Korea. genice@hiramail.net

Pharmacoeconomics
|January 17, 2013
PubMed
Summary

The Korean guidelines for pharmacoeconomic evaluation were revised by the Health Insurance Review and Assessment Service (HIRA) to enhance clarity and comparability. The updated guidelines offer more specific instructions for economic studies and data requirements.

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Area of Science:

  • Health Economics
  • Pharmacoeconomics
  • Health Technology Assessment

Background:

  • The initial Korean pharmacoeconomic evaluation guidelines were published in 2006 by HIRA.
  • Accumulated domestic experience and methodological advancements necessitated a revision of the guidelines.

Purpose of the Study:

  • To document the revision process for the Korean pharmacoeconomic evaluation guidelines.
  • To present the content of the newly revised guidelines.

Main Methods:

  • Conducted multiple meetings with an advisory committee and pharmaceutical companies.
  • Incorporated feedback from a survey of pharmaceutical companies and decision-makers on the existing guidelines.
  • Revised guidelines based on consensus-building and stakeholder input.

Main Results:

  • Introduced a tiered data requirement system ('must', 'recommended', 'preferred').
  • Updated guidance on the perspective for economic studies and Quality-Adjusted Life Year (QALY) measurement.
  • Published manuals for systematic reviews and indirect comparisons, and added a standardized reporting format for expert opinions.
  • Clarified methods for evaluations, sensitivity analysis, modeling, and time horizon.
  • Enhanced user-friendliness and specificity of recommendations for improved quality and comparability.

Conclusions:

  • The revised guidelines provide clearer, more user-friendly recommendations for pharmacoeconomic evaluations.
  • The updates aim to improve the quality and consistency of health economic submissions in Korea.