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

Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

405
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...
405
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

279
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...
279
Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

2.0K
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
2.0K
Preclinical Development: Overview01:28

Preclinical Development: Overview

6.3K
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...
6.3K
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

4.9K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
4.9K
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

470
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...
470

You might also read

Related Articles

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

Sort by
Same author

A narrative review on nanogel-based topical delivery of chemotherapeutic and phytoagents for non- melanoma skin cancer treatment.

Therapeutic delivery·2026
Same author

Nanostructured Lipid Carriers in Drug Targeting: Characterization, Patents, and Recent Innovations.

Current pharmaceutical design·2026
Same author

Bioanalytical RP-HPLC Method Development and Validation for Simultaneous Estimation of Temozolomide and Resveratrol: A Pharmacokinetic Analysis in Rat Plasma and Brain.

Biomedical chromatography : BMC·2026
Same author

Impact of post approval quantitative changes in excipient composition on nitrosamine formation: De-risking strategy.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2026
Same author

Harnessing plant growth-promoting bacteria for nanoparticle biosynthesis: a systematic review of mechanisms, agricultural applications, and biomedical potential.

Bioprocess and biosystems engineering·2026
Same author

Chitosan nanoparticles for brain targeted nose-to-brain drug delivery in neurodegenerative disease: a comprehensive exploration of advances, limitations and future prospects.

Expert opinion on drug delivery·2026

Related Experiment Video

Updated: Mar 15, 2026

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

4.5K

Pharmaceutical product development: A quality by design approach.

Kannissery Pramod1, M Abu Tahir2, Naseem A Charoo3

  • 1College of Pharmaceutical Sciences, Government Medical College, Kozhikode, Kerala, India.

International Journal of Pharmaceutical Investigation
|September 9, 2016
PubMed
Summary

Quality by Design (QbD) principles enhance pharmaceutical development, leading to faster regulatory approval and fewer post-approval changes. Implementing QbD ensures a science-based approach for successful drug product lifecycle management.

Keywords:
Design of experimentsQbDQuality by Designdesign spaceprocess analytical technologyrisk assessment

More Related Videos

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

9.4K
A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
13:54

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

Published on: August 18, 2023

6.2K

Related Experiment Videos

Last Updated: Mar 15, 2026

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

4.5K
Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

9.4K
A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
13:54

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

Published on: August 18, 2023

6.2K

Area of Science:

  • Pharmaceutical Science
  • Regulatory Science
  • Drug Development

Background:

  • Quality by Design (QbD) is a key focus for regulatory bodies and the pharmaceutical industry.
  • International Conference on Harmonization and USFDA guidance highlight QbD principles in pharmaceutical development.
  • QbD is integrated into regulatory reviews, such as the USFDA's question-based review for abbreviated new drug applications.

Purpose of the Study:

  • To review the principles and applications of Quality by Design (QbD) in pharmaceutical product development.
  • To highlight the importance of QbD in fostering a science-based approach.
  • To discuss key QbD elements and their role in ensuring product performance.

Main Methods:

  • Review of QbD principles and their implementation in pharmaceutical development.
  • Discussion of key QbD elements: target product quality profile, critical quality attributes, risk assessments, design space, control strategy, and lifecycle management.
  • Exploration of tools like Design of Experiments, risk assessment, and Process Analytical Technology in QbD.

Main Results:

  • QbD implementation leads to successful product development and prompt regulatory approval.
  • Adoption of QbD principles significantly reduces validation burden and post-approval changes.
  • QbD facilitates understanding of dosage form performance within the defined design space.

Conclusions:

  • Quality by Design (QbD) is crucial for a science-based approach in pharmaceutical product development.
  • Effective implementation of QbD elements ensures product quality and regulatory compliance.
  • QbD supports continuous improvement and efficient lifecycle management of pharmaceutical products.