ReviewThe AAPS journal2016
A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products.
Review in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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
22 citing papers in PubMed.
- High-Pressure Homogenization (HPH)-Based Bioactive-Loaded Nanocarriers in the Food Industry: Principles, Applications, and Challenges.Comprehensive reviews in food science and food safety · 2026Review
- Engineered nanomedicine remodels the postoperative cavity microenvironment to suppress glioblastoma recurrence.Theranostics · 2026Review
- Application of quality by design in optimization of nanoformulations: Principle, perspectives and practices.Drug delivery and translational research · 2025Review
- QbD-driven Formulation Development and Evaluation of Genistein Nanoparticles for Prostate Cancer.Recent advances in drug delivery and formulation · 2025Article
- A translational framework to DELIVER nanomedicines to the clinic.Nature nanotechnology · 2024Review
- The Artificial Intelligence-Powered New Era in Pharmaceutical Research and Development: A Review.AAPS PharmSciTech · 2024Review
- A Review of the Potential of Poly-(lactide-co-glycolide) Nanoparticles as a Delivery System for an Active Antimycobacterial Compound, 7-Methyljuglone.Pharmaceutics · 2024Review
- Regulatory Procedures and Integrated Requirements for Early Phase Development of a Pharmaceutical Drug Product.Reviews on recent clinical trials · 2024Article
- Process Robustness in Lipid Nanoparticle Production: A Comparison of Microfluidic and Turbulent Jet Mixing.Molecular pharmaceutics · 2023Article
- Artificial Intelligence in Pharmaceutical Technology and Drug Delivery Design.Pharmaceutics · 2023Review
- Current approaches of nanomedicines in the market and various stage of clinical translation.Acta pharmaceutica Sinica. B · 2022Review
- Article
- The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.Pharmaceutics · 2022Review
- A Systematic, Knowledge Space-Based Proposal on Quality by Design-Driven Polymeric Micelle Development.Pharmaceutics · 2021Article
- Current State and Promising Opportunities on Pharmaceutical Approaches in the Treatment of Polymicrobial Diseases.Pathogens (Basel, Switzerland) · 2021Review
- Different PEG-PLGA Matrices Influence In Vivo Optical/Photoacoustic Imaging Performance and Biodistribution of NIR-Emitting π-Conjugated Polymer Contrast Agents.Advanced healthcare materials · 2021Article
- Nanotechnological strategies for systemic microbial infections treatment: A review.International journal of pharmaceutics · 2020Review
- Critical quality attributes in the development of therapeutic nanomedicines toward clinical translation.Drug delivery and translational research · 2020Review
- Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision.Frontiers in medicine · 2020Review
- A Methodological Safe-by-Design Approach for the Development of Nanomedicines.Frontiers in bioengineering and biotechnology · 2020Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The translation of nanomedicines from concepts to commercial products has not reached its full potential, in part because of the technical and regulatory challenges associated with chemistry, manufacturing, and controls (CMC) development of such complex products. It is critical to take a quality by design (QbD) approach to developing nanomedicines-using a risk-based approach to identifying and classifying product attributes and process parameters and ultimately developing a deep understanding of the products, processes, and platform. This article exemplifies a QbD approach used by BIND Therapeutics, Inc., to industrialize a polymeric targeted nanoparticle drug delivery platform. The focus of the approach is on CMC affairs but consideration is also given to preclinical, clinical, and regulatory aspects of pharmaceutical development. Processes are described for developing a quality target product profile and designing supporting preclinical studies, defining critical quality attributes and process parameters, building a process knowledge map, and employing QbD to support outsourced manufacturing.
Indexed as
Identifiers
27631558What 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.