Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Therapeutic Drug Monitoring: Drug Analysis Methods01:26

Therapeutic Drug Monitoring: Drug Analysis Methods

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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...
Data Validation01:15

Data Validation

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.
Key parameters for method validation include:
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

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...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Intestinal Smooth Muscle Macrophages: Linking the ENS and CNS in Parkinson's Disease.

Gastroenterology·2026
Same author

Validation of Family Medicine Point-of-Care Ultrasound Screening (POCUS) for Abdominal Aortic Aneurysm.

Journal of the American Board of Family Medicine : JABFM·2026
Same author

Neurogastroenterology and Motility: Toward New Horizons in 2026.

Neurogastroenterology and motility·2026
Same author

Front line child welfare perspectives on the utility and implementation of intensive family preservation services.

Children and youth services review·2026
Same author

Combining UV-Vis Absorption and FRET Melting Curves to Screen the Thermodynamic Stability and Folding Pathways of Nucleic Acids In Vitro.

Methods in molecular biology (Clifton, N.J.)·2026
Same author

Profiling the Enteric Nervous System.

Gastroenterology·2025
Same journal

Updated Recommendations for the Bioanalysis of Antibody-Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical Community.

The AAPS journal·2026
Same journal

In vivo Predictive Dissolution Test Using Biorelevant Bicarbonate Buffer for High-dose Free Acid Drug.

The AAPS journal·2026
Same journal

Whole-Body Pharmacokinetics of Ionizable Lipid, mRNA, and the Expressed Antibody following Intravenous Administration of mRNA-Loaded Lipid Nanoparticles.

The AAPS journal·2026
Same journal

Simple Hydrodynamic Molecular Weight Model for Rapid Assessment of Therapeutic Protein Oligomerization States in Formulation.

The AAPS journal·2026
Same journal

Guiding the Molnupiravir Tablet Formulation Using Physiologically Based Biopharmaceutics Modeling and Successfully Establishing Dissolution Safe Space.

The AAPS journal·2026
Same journal

Correction: Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation.

The AAPS journal·2026
See all related articles

Related Experiment Video

Updated: Jun 10, 2026

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
08:59

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

Published on: December 3, 2020

Nonclinical dose formulation analysis method validation and sample analysis.

Monica Lee Whitmire1, Peter Bryan, Teresa R Henry

  • 1MPI Research, Mattawan, Michigan, USA. monica.whitmire@mpiresearch.com

The AAPS Journal
|August 17, 2010
PubMed
Summary
This summary is machine-generated.

This study addresses the lack of regulatory guidance for nonclinical dose formulation analysis. It proposes best practices and acceptance criteria for method validation and sample analysis in regulated nonclinical studies.

More Related Videos

Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry
08:56

Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry

Published on: November 22, 2024

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Related Experiment Videos

Last Updated: Jun 10, 2026

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
08:59

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

Published on: December 3, 2020

Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry
08:56

Detection of Regulated Ergot Alkaloids in Food Matrices by Liquid Chromatography-Trapped Ion Mobility Spectrometry-Time-of-Flight Mass Spectrometry

Published on: November 22, 2024

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Area of Science:

  • Pharmacology and Toxicology
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Nonclinical dose formulation analysis confirms test article concentration, homogeneity, and stability for regulated studies.
  • Currently, no specific regulatory guidance exists for validating these methods or analyzing samples.
  • Existing guidance for analytical procedures (drug product testing) and bioanalytical methods offers partial overlap but differs in acceptance criteria.

Purpose of the Study:

  • To reconcile current practices in nonclinical dose formulation analysis.
  • To provide recommendations for best practices in method validation and sample analysis.
  • To propose specific acceptance criteria tailored for nonclinical dose formulation studies.

Main Methods:

  • Comparative analysis of existing regulatory guidance for analytical procedures and bioanalysis.
  • Identification of overlapping and divergent validation parameters (e.g., accuracy, precision, stability).
  • Evaluation of the applicability of standard bioanalytical acceptance criteria to formulation analysis.

Main Results:

  • Key validation parameters like recovery, accuracy, precision, specificity, selectivity, carryover, sensitivity, and stability are common to both bioanalysis and formulation analysis.
  • Differences in acceptance criteria are noted, particularly concerning quality control samples and target concentration deviations.
  • The paper highlights that formulation samples are not true "unknowns," impacting the necessity of certain bioanalytical quality control concepts.

Conclusions:

  • There is a need for harmonized best practices and acceptance criteria for nonclinical dose formulation analysis.
  • Recommendations are provided to bridge the gap between current practices and regulatory expectations.
  • Implementing proposed criteria will enhance the reliability and consistency of nonclinical study data.