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

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Preclinical Development: Overview01:28

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 Validation01:10

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...
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...
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...

You might also read

Related Articles

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

Sort by
Same author

Health Data Quality Skill Gaps and Training Needs Among European Health Data Stakeholders: Cross-Sectional Survey.

Journal of medical Internet research·2026
Same author

Acute brain dysfunction clusters in COVID-19: a pilot machine learning-based analysis of the COVID-D cohort.

Intensive care medicine experimental·2026
Same author

Overrepresentation Bias Leads to Performance Overestimation in Blood-Brain Barrier Permeability Prediction Models: Characterization and Mitigation.

Journal of chemical information and modeling·2026
Same author

Correction: Clinically significant prostate cancer detection with deep learning in a multi-center magnetic resonance imaging study.

Scientific reports·2026
Same author

Clinically significant prostate cancer detection with deep learning in a multi-center magnetic resonance imaging study.

Scientific reports·2026
Same author

Automated delineation of putative non-contrast-enhancing tumor in glioblastoma: Prognostic insights.

Neuro-oncology·2026

Related Experiment Video

Updated: Jul 7, 2026

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
06:47

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells

Published on: October 6, 2023

Developing Scientific Software According to Pharmaceutical Regulatory Compliance: A GAMP-Based Methodology.

Ángel Sánchez-García1, Marta Durá1, Carlos Sáez1

  • 1Biomedical Data Science Laboratory, Instituto Universitario de Tecnologías de la Información y Comunicaciones (ITACA), Universitat Politècnica de València, 46022 Valencia, Spain.

Studies in Health Technology and Informatics
|May 17, 2025
PubMed
Summary

Research institutions can improve scientific software for industry use by adopting Good Manufacturing Practices (GMP). This methodology ensures compliance and facilitates technology transfer to the pharmaceutical sector.

Keywords:
GAMP 5Industry-Academia CollaborationMethodologyPharmaceutical industryScientific Software

More Related Videos

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
07:43

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears

Published on: July 14, 2023

Related Experiment Videos

Last Updated: Jul 7, 2026

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
06:47

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells

Published on: October 6, 2023

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears
07:43

A Validatable Droplet Digital Polymerase Chain Reaction Assay for the Detection of Adeno-Associated Viral Vectors in Bioshedding Studies of Tears

Published on: July 14, 2023

Area of Science:

  • Scientific software development
  • Pharmaceutical industry
  • Regulatory compliance

Background:

  • Research software often lacks formal documentation, hindering its application beyond academia.
  • Pharmaceutical collaborations require adherence to Good Manufacturing Practices (GMP) for operational deployment.
  • Bridging the gap between academic research software and industry standards is crucial.

Purpose of the Study:

  • To propose a GMP-based methodology for research institutions.
  • To enhance the usability and transferability of scientific software.
  • To ensure research software meets pharmaceutical industry compliance standards.

Main Methods:

  • A four-stage methodology: project premise, prototyping, GAMP 5 V-Model development, and software transference.
  • Tailoring GMP guidelines for the specific context of research institutions.
  • Integrating documentation and compliance throughout the software development lifecycle.

Main Results:

  • Accelerated development cycles for scientific software.
  • Ensured compliance with Good Manufacturing Practices (GMP).
  • Facilitated seamless transfer of R&D results to the pharmaceutical industry.

Conclusions:

  • The proposed methodology effectively bridges the gap between research and industry.
  • Implementing GMP guidelines enhances scientific software's value and applicability.
  • This approach supports the commercialization of academic research through industry partnerships.