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

Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Design Consideration01:22

Design Consideration

Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
The factor of safety is another key aspect...
Good Manufacturing Practices01:26

Good Manufacturing Practices

Good Manufacturing Practices (GMP) constitute a foundational set of guidelines that ensure the production of safe, consistent, and high-quality products, particularly in industries such as pharmaceuticals, biotechnology, and food processing. These protocols encompass all aspects of production, from the sourcing of raw materials to the final distribution of the finished product.A core pillar of GMP is stringent hygiene and sanitation across all production environments. This includes routine...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
Quality Control01:05

Quality Control

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
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...

You might also read

Related Articles

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

Sort by
Same author

Simulation of nitrosamine drug substance-related impurities from secondary amine-related impurities in approved human drug products.

Journal of pharmaceutical sciences·2026
Same author

Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets.

International journal of pharmaceutics·2024
Same author

Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances.

Journal of pharmaceutical sciences·2024
Same author

Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters.

Pharmaceutics·2024
Same author

A network of regulatory innovations to improve FDA quality assessments of human drug applications.

International journal of pharmaceutics: X·2024
Same author

Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets.

Journal of pharmaceutical sciences·2023
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: Jul 5, 2026

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control
05:47

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control

Published on: August 29, 2025

Quality by design: concepts for ANDAs.

Robert A Lionberger1, Sau Lawrence Lee, Laiming Lee

  • 1Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland, 20855, USA.

The AAPS Journal
|May 10, 2008
PubMed
Summary
This summary is machine-generated.

This paper clarifies Quality by Design (QbD) terminology for generic drugs, proposing consistent nomenclature for key elements like critical quality attributes and control strategies to aid regulatory submissions.

Related Experiment Videos

Last Updated: Jul 5, 2026

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control
05:47

Simulation of a Scaled Assembly Process with Collaboration of a Robotic Arm and Monitoring through a Vision System for Quality Control

Published on: August 29, 2025

Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Regulatory Science

Background:

  • Quality by Design (QbD) is crucial for modern pharmaceutical quality.
  • Confusion exists regarding QbD elements and terminology within the generic drug industry.

Purpose of the Study:

  • To clarify QbD principles and terminology for generic drug development.
  • To propose a consistent nomenclature for key QbD concepts.

Main Methods:

  • Review and examination of existing QbD elements.
  • Development of a proposed consistent terminology for QbD, critical quality attribute (CQA), critical process parameter (CPP), critical material attribute (CMA), and control strategy.

Main Results:

  • Identified key elements of QbD relevant to generic drugs.
  • Proposed a unified nomenclature for QbD, CQA, CPP, CMA, and control strategy.

Conclusions:

  • Establishing agreement on QbD terminology is essential for advancing its application in generic drug development.
  • Standardized terminology will facilitate discussions on applying QbD to abbreviated new drug applications (ANDAs).