Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Clinically Relevant Drug Product Specifications: Methods of Establishment

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...

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...

Drug Product Stability

Drug Product Stability

The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses

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...

Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

In Vitro Drug Release Testing: Overview, Development and Validation

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...

You might also read

Related Articles

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

Sort by

Same author

Hikikomori Risk in the UK.

The International journal of social psychiatry·2025

Same author

Investigating the therapeutic potential of 1,2,3,4,6 penta-O-galloyl-β-D-glucose in Alzheimer's disease: a scoping review.

Natural product research·2025

Same author

A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities.

The AAPS journal·2025

Same author

Mass balance analysis for therapeutic peptides: Case studies, applications, and perspectives.

Journal of pharmaceutical and biomedical analysis·2024

Same author

Worth a Shot: Experience and Lessons From an Unsuccessful Pediatric Immunization Quality Improvement Effort in a Large Health System During the COVID-19 Pandemic.

Military medicine·2024

Same author

Carprofen Attenuates Postoperative Mechanical and Thermal Hypersensitivity after Plantar Incision in Immunodeficient NSG Mice.

Comparative medicine·2024

Search research articles

Related Experiment Video

Updated: Mar 15, 2026

Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods

Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods

Published on: April 14, 2023

Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations.

Teresa R Henry¹, Lara D Penn², Jason R Conerty³

¹Chemistry and Manufacturing Controls, Sequoia Consulting, 125 N. Acacia Ave, Solana Beach, California, 92075, USA. Teresa.Henry@SequoiaSolution.com.

The AAPS Journal

|September 8, 2016

Summary

Developing stability-indicating methods for non-clinical dose formulations is crucial for drug development. These methods ensure accurate quantification of active pharmaceutical ingredients (APIs) and impurities, supporting safety assessments in human studies.

Keywords:

GLP impurity non-clinical dose formulation analysis stability indicating validation

More Related Videos

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

Related Experiment Videos

Last Updated: Mar 15, 2026

Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods

Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods

Published on: April 14, 2023

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

Area of Science:

Pharmaceutical Sciences
Drug Development
Analytical Chemistry

Background:

Non-clinical dose formulations are essential for early drug development, enabling pharmacokinetic and toxicological studies.
Accurate assessment of active pharmaceutical ingredients (APIs), impurities, and degradation products is critical for supporting human study safety and dosage.
Stability-indicating methods are vital for generating reliable data on API concentration, pharmacokinetics, and pharmacodynamics.

Purpose of the Study:

To provide an overview of best practices for developing and validating stability-indicating methods for non-clinical drug development.
To support teams new to or less familiar with stability-indicating method development and validation requirements.
To ensure accurate detection and quantification of APIs, impurities, and degradation products in pre-clinical formulations.

Main Methods:

Development and validation of analytical methods capable of detecting and quantifying APIs.
Quantification of process impurities and degradation products alongside the API.
Generation of trendable results predictive of drug product stability.

Main Results:

Validated methods provide accurate and reliable data on API concentration and purity.
Identification and quantification of potential impurities and degradation products.
Trendable results aid in predicting drug product stability and informing safety assessments.

Conclusions:

Stability-indicating methods are indispensable for robust non-clinical drug development.
These methods ensure the safety and efficacy of drug candidates by characterizing APIs and their associated impurities.
Adherence to best practices in method development and validation is key to successful drug development programs.