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Related Concept Videos

Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
Dose Size and Dosing Frequency: Determination Methods01:21

Dose Size and Dosing Frequency: Determination Methods

Determining the optimal dose size and dosing frequency in pharmacotherapy is crucial for achieving therapeutic effectiveness while minimizing adverse effects. This article explores the methodologies employed in determining these parameters, focusing on their significance and interplay to tailor dosing regimens.Dose Size: Dose size refers to the amount of a drug administered in a single dose. It is determined based on the drug's pharmacodynamics and pharmacokinetics properties and...
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

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...
Measurement of Bioavailability: Pharmacodynamic Methods01:20

Measurement of Bioavailability: Pharmacodynamic Methods

Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
Hallucinogens and Psychedelics01:27

Hallucinogens and Psychedelics

Hallucinogens are psychoactive substances that profoundly alter perceptual experiences, generating unreal visual and sensory images. Often referred to as psychedelic drugs — a term derived from the Greek words "psyche" (mind) and "delos" (revealing) — these substances include marijuana and lysergic acid diethylamide (LSD), among others. These drugs vary in intensity and effects.
Marijuana, derived from the dried leaves and flowers of the hemp plant, contains delta-9-tetrahydrocannabinol (THC)...

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Microinjectrode System for Combined Drug Infusion and Electrophysiology
08:30

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Published on: November 13, 2019

Microdosing: concept, application and relevance.

Tushar Tewari1, Shoibal Mukherjee

  • 1Manager, Medical Affairs, GVK Biosciences.

Perspectives in Clinical Research
|August 11, 2011
PubMed
Summary
This summary is machine-generated.

Microdosing pharmacokinetic studies offer cost savings and efficiency in drug development but face adoption hurdles. Regulatory clarity in Europe and the US aids adoption, contrasting with India

Keywords:
AMSBioanalysisExploratory INDISCRMicrodosingPhase 0

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Area of Science:

  • Pharmacokinetics and Drug Development

Background:

  • Microdosing pharmacokinetic studies are an underutilized tool in pharmaceutical research.
  • This approach offers significant potential for cost reduction and efficiency gains in drug development.
  • Widespread adoption is hindered by several challenges.

Purpose of the Study:

  • To evaluate the current status and future prospects of microdosing studies in drug development.
  • To highlight the impact of regulatory frameworks on the implementation of microdosing.
  • To assess the inconsistency in Indian regulatory provisions for microdosing studies.

Main Methods:

  • Analysis of existing literature and regulatory landscapes in Europe, USA, and India.
  • Assessment of the benefits and challenges associated with microdosing pharmacokinetic studies.
  • Comparative review of regulatory approaches towards microdosing.

Main Results:

  • Clear regulations in Europe and the USA have facilitated the use of microdosing.
  • Significant hurdles remain for the technique to become a routine part of drug development.
  • India lacks specific regulatory provisions for microdosing studies, despite their relevance and low risk.

Conclusions:

  • Microdosing pharmacokinetic studies present a valuable opportunity for efficient drug development.
  • Harmonized and enabling regulations are crucial for the widespread adoption of microdosing.
  • India's regulatory framework needs to evolve to support this innovative approach and align with its pharmaceutical research ambitions.