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

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...
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...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

You might also read

Related Articles

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

Sort by
Same author

Air Entrainment and Subsequent Pneumocephalus Associated with Epidural Blood Patch.

Anesthesiology·2026
Same author

Thalamo-cortical synchrony shapes seizure expression in human temporal lobe epilepsy.

Nature communications·2026
Same author

Thalamic interictal epileptic and non-epileptic events during NREM sleep in patients with focal epilepsy: a Stereo-EEG study.

EBioMedicine·2026
Same author

Probiotics and prebiotics as alternatives to antibiotics in aquaculture: a systematic and bibliometric review of antimicrobial and antioxidant mechanisms.

Frontiers in microbiology·2026
Same author

Risk factors affecting tissue expander use and nipple areolar complex sparing in Goldilocks mastectomy.

Journal of plastic, reconstructive & aesthetic surgery : JPRAS·2026
Same author

Impact of antiseizure medication taper on electroencephalographic dynamics in focal epilepsy: A stereoelectroencephalographic study.

Epilepsia·2026
Same journal

Green, renewable, or low-carbon? A framework for informed solvent selection in pharmaceutical sciences.

Journal of pharmaceutical sciences·2026
Same journal

Theranostic potential of ramucirumab functionalized magnetoliposomes for targeted delivery of sorafenib and MRI.

Journal of pharmaceutical sciences·2026
Same journal

Intranasal mucoadhesive chitosan microspheres of ranolazine: Formulation, design, and pharmacokinetic evaluation.

Journal of pharmaceutical sciences·2026
Same journal

Evolving landscape of drug development for pediatric rare diseases-from successes to strategies for addressing unmet needs.

Journal of pharmaceutical sciences·2026
Same journal

A mathematical framework for predicting tablet weight variability from blend particle size distribution and tooling geometry.

Journal of pharmaceutical sciences·2026
Same journal

Recrystallization can stop nitrosamine formation in ranitidine hydrochloride.

Journal of pharmaceutical sciences·2026
See all related articles

Related Experiment Video

Updated: May 20, 2026

Digital Microfluidics for Automated Proteomic Processing
10:55

Digital Microfluidics for Automated Proteomic Processing

Published on: November 6, 2009

Automation and digitalization in drug product process development.

Sadegh Poozesh1, Mike Long2, Robert Frederick Meyer1

  • 1Pharmaceutical Commercialization Technology, Merck & Co., Inc., Rahway, NJ, USA.

Journal of Pharmaceutical Sciences
|May 18, 2026
PubMed
Summary
This summary is machine-generated.

Pharmaceutical automation, including large language model (LLM)-based chatbots, streamlines drug product development and regulatory processes. These digital tools enhance efficiency, data integrity, and compliance within Good Documentation Practices (GDP).

Keywords:
Artificial intelligenceChemistry, manufacturing, and controls (CMC)Digital transformationDigital twinDrug product developmentLarge language modelProcess automationRegulatory compliance

More Related Videos

Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays
08:06

Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays

Published on: November 10, 2016

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
07:48

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

Related Experiment Videos

Last Updated: May 20, 2026

Digital Microfluidics for Automated Proteomic Processing
10:55

Digital Microfluidics for Automated Proteomic Processing

Published on: November 6, 2009

Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays
08:06

Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays

Published on: November 10, 2016

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
07:48

A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics

Published on: September 22, 2011

Area of Science:

  • Pharmaceutical Science and Technology
  • Digital Transformation in Life Sciences
  • Automation and Process Engineering

Background:

  • The pharmaceutical industry is experiencing a digital transformation driven by the need for efficiency and cost reduction.
  • Automation is a key strategy to streamline drug product (DP) process development and enhance operational efficiency.
  • Existing processes often lack integration, leading to inefficiencies in data management, documentation, and regulatory interactions.

Purpose of the Study:

  • To explore current trends and practical implementations of automation in pharmaceutical process development.
  • To highlight the role of emerging technologies, such as large language model (LLM)-based chatbots, in pharmaceutical operations.
  • To discuss the integration of automation within Good Documentation Practices (GDP) frameworks for regulatory compliance.

Main Methods:

  • Review of current trends and practical implementations of automation across key pharmaceutical areas.
  • In-depth analysis of mature technologies and innovative tools in automation, including LLM-based chatbots.
  • Examination of real-world applications and case studies illustrating the benefits of automation.

Main Results:

  • Automation is being implemented in data management, documentation, unit operations, regulatory query (RTQ) handling, and submission preparation.
  • LLM-based chatbots are emerging as valuable tools for knowledge management, RTQ responses, and task automation.
  • Automation offers benefits such as improved data integrity, shortened development timelines, and enhanced regulatory compliance.

Conclusions:

  • Automation, particularly with LLM integration, is revolutionizing pharmaceutical process development and operations.
  • Successful deployment requires adherence to Good Documentation Practices (GDP) to ensure quality, traceability, and compliance.
  • The adoption of these digital solutions is critical for pharmaceutical companies to remain competitive and compliant.