ReviewPharmaceutics2021
Process Analytical Technology Tools for Monitoring Pharmaceutical Unit Operations: A Control Strategy for Continuous Process Verification.
Review in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it, 137 citations in OpenAlex.
- A Comprehensive Review of the Revolutionary Potential of Blockchain in Safe, Secure, and Sustainable Pharmaceutical Operations.Pharmaceutical research · 2026Pooled it
- Advances in Cubosome-Based Transdermal Delivery: Structural Design, Manufacturing, and Engineering Strategies.ACS omega · 2026Review
- Bridging data and theory: hybrid modelling for pharmaceutical crystallisation process development.Digital discovery · 2026Review
- Artificial intelligence-driven digital twins in Pharma 4.0: transforming smart manufacturing, predictive quality assurance, and personalized drug delivery.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Review
- Do We Still Need Chemistry for Water-Soluble Prodrugs? What Biocatalysis Already Does, and What It Does Not.Pharmaceutics · 2026Review
- Process Analytical Technology Integration in 3D Printing Processes: Benefits and Challenges.AAPS PharmSciTech · 2026Review
- Review
- Lipid-Based Delivery Systems for Therapeutic Glycoproteins: Current Advances, Challenges, and Future Perspectives.Pharmaceutics · 2026Review
- Quality by Design and Process Analytical Technology for On-Demand Drug Manufacturing Through 3D Printing.Pharmaceutics · 2026Review
- Advanced herbal self-assembled nanoplatforms: targeted, stimuli-responsive, and precision therapeutics for human diseases.Journal of nanobiotechnology · 2026Review
- Impurity Characterization Across Drug Development Stages: Analytical Methodologies and Regulatory Perspectives.Pharmaceutical research · 2026Review
- Liposome Particle Size Prediction by In-Line Process Analytical Technology (PAT)-Integrated Machine Learning.Small methods · 2026Article
- A Bioinspired Approach to Next-Generation Vaccines in Solid Tumors with Engineered Cell Membranes.Research (Washington, D.C.) · 2026Review
- Biomimetic Cell Membrane-coated Nanovaccines in Anti-tumor Immunotherapy.Theranostics · 2026Review
- Design Evolution of Curcumin-Loaded Nanostructured Lipid Carriers: Formulation Strategies, Functional Modifications, and Mechanistic-Translational Perspectives.International journal of nanomedicine · 2026Review
- Recent trends in pharmaceutical freeze-drying and control strategies observed in human drug applications and manufacturing inspections.AAPS open · 2025Article
- Real-time monitoring of selective laser sintering 3D printing process for lamivudine content quantification in the printlets: a modern solution to a modern problem.International journal of pharmaceutics · 2025Article
- A process analyzer assembly for real-time automated near-infrared, Raman, and proton nuclear magnetic resonance spectroscopic monitoring enhanced by heterocovariance spectroscopy and chemometry applied to a Schiff base formation.Analytical and bioanalytical chemistry · 2025Article
- Recent Techniques to Improve Amorphous Dispersion Performance with Quality Design, Physicochemical Monitoring, Molecular Simulation, and Machine Learning.Pharmaceutics · 2025Review
- Artificial intelligence-aided endoscopic in-line particle size analysis during the pellet layering process.Journal of pharmaceutical analysis · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls and predefined material attributes and intermediate quality attributes (IQAs) during processing may provide greater assurance of product quality than end-product testing. The efficient analysis method to monitor the relationship between process and quality should be used. Process analytical technology (PAT) was introduced to analyze IQAs during the process of establishing regulatory specifications and facilitating continuous manufacturing improvement. Although PAT was introduced in the pharmaceutical industry in the early 21st century, new PAT tools have been introduced during the last 20 years. In this review, we present the recent pharmaceutical PAT tools and their application in pharmaceutical unit operations. Based on unit operations, the significant IQAs monitored by PAT are presented to establish a control strategy for CPV and real time release testing (RTRT). In addition, the equipment type used in unit operation, PAT tools, multivariate statistical tools, and mathematical preprocessing are introduced, along with relevant literature. This review suggests that various PAT tools are rapidly advancing, and various IQAs are efficiently and precisely monitored in the pharmaceutical industry. Therefore, PAT could be a fundamental tool for the present QbD and CPV to improve drug product quality.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.