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Related Concept Videos

Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

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Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
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Dosage Regimen: Individualization01:24

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Determination of Multiple Dosing Parameters: Loading and Maintenance Doses01:25

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses

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A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...
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Analysis of Population Pharmacokinetic Data01:12

Analysis of Population Pharmacokinetic Data

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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...
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Pharmacovigilance01:19

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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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Methods to Investigate the Regulatory Role of Small RNAs and Ribosomal Occupancy of Plasmodium falciparum
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Variability in malaria prophylaxis prescribing across Europe: a Delphi method analysis.

Guido Calleri1, Ron H Behrens, Zeno Bisoffi

  • 1Department of Infectious Diseases, Travel Medicine Unit, Amedeo di Savoia Hospital, Torino, Italy. calleri@asl3.to.it

Journal of Travel Medicine
|November 14, 2008
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Summary

Malaria chemoprophylaxis prescribing lacks evidence, leading to varied practices. Further European discussion and evidence on efficacy are needed for harmonization.

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Area of Science:

  • Travel Medicine
  • Infectious Disease Epidemiology

Background:

  • Current guidelines for malaria chemoprophylaxis lack robust evidence.
  • This results in subjective and inconsistent prescribing practices across Europe.

Purpose of the Study:

  • To assess European expert consensus on malaria chemoprophylaxis prescribing.
  • To identify areas for harmonization in clinical practice.

Main Methods:

  • Utilized the Delphi method with European travel medicine experts from TropNetEurop.
  • Conducted iterative surveys on prescribing controversies, drug characteristics, and practical scenarios.

Main Results:

  • Initial consensus increased after the first Delphi round.
  • Consensus was reached in 8 out of 14 practical scenarios.
  • Significant regional variations in prescribing preferences were observed across Europe.

Conclusions:

  • There is a need for improved evidence on the efficacy, tolerability, and malaria risk associated with chemoprophylaxis.
  • Harmonization of prescribing practices requires further European expert dialogue.