ReviewBiomedicines2023
Quality by Design (QbD) and Design of Experiments (DOE) as a Strategy for Tuning Lipid Nanoparticle Formulations for RNA Delivery.
Review in Biomedicines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
What it found
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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.
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Who cites it
29 citing papers in PubMed.
- Self-amplifying RNA (saRNA) and circular RNA (circRNA) vaccines: Progress, evidence gaps, and translational pathways for durable and scalable immunization.Human vaccines & immunotherapeutics · 2026Review
- Revisiting the lipid ratio in lipid nanoparticles: A comparison of OFAT and design of experiments approaches.Drug delivery and translational research · 2026Article
- From bench to bedside: Overcoming translational hurdles in nanoparticle research with pharmacokinetic modeling.Bioengineering & translational medicine · 2026Review
- From Screening to Optimization: Strategic Implementation of Design of Experiments (DOE) for Robust Nanoparticle Formulation.Polymers · 2026Review
- Pulmonary Drug Delivery in the Era of Nanomedicine: From Biological Barriers to Artificial Intelligence-Driven Optimization.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Data-driven full-chain quality control for Xiaoer Chiqiao Qingre granules: from process risk management to intelligent product testing.Chinese medicine · 2026Article
- Emerging Non-Conventional Approaches in mRNA-LNP Formulation for Therapeutic Applications.Pharmaceutics · 2026Review
- Industrial Perspective on the Manufacturing of Lipid Nanoparticles for Nucleic Acid Delivery.Pharmaceutics · 2026Review
- QbD product development: rapid optimization and scale-up of PBAE-based siRNA deliveryRSC pharmaceutics · 2026Article
- PLGA-Based In Situ-Forming Implants, a Quality by Design Perspective.Pharmaceutics · 2026Review
- Cell-Laden Supramolecular and Covalent Polymer Hydrogels for High-Shear Delivery: A Design of Experiments Approach.Chemistry of materials : a publication of the American Chemical Society · 2026Article
- Unconventional Lysine-Type Lipid Assemblies Enable Efficient Antisense Oligonucleotide Delivery with Distinct Structural Features.Pharmaceutics · 2026Article
- Quality by design in public healthcare: a rapid development framework for future pandemics.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026Review
- Nanomedicine for Benign Prostatic Hyperplasia: Pathological Axes and Translational Evidence.International journal of nanomedicine · 2026Review
- Article
- PLGA-Based Co-Delivery Nanoformulations: Overview, Strategies, and Recent Advances.Pharmaceutics · 2025Review
- Advances in the application of lipid nanocapsules and nanostructured carriers in the treatment of lung cancer.Nanomedicine (London, England) · 2025Review
- Development and evaluation of targeted liposomes for improved doxorubicin and quercetin delivery for MDR breast cancer.Therapeutic delivery · 2025Article
- Optimization of a Dissolvable Lipid Nanoparticle Microneedle Formulation for mRNA Delivery Using Design of Experiments.ACS applied materials & interfaces · 2025Article
- Quality by Design and In Silico Approach in SNEDDS Development: A Comprehensive Formulation Framework.Pharmaceutics · 2025Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The successful development of nonviral delivery systems for nucleic acids has been reported extensively over the past years. Increasingly employed to improve the delivery efficiency and therapeutic efficacy of RNA are lipid nanoparticles (LNPs). Many of the various critical formulation parameters can affect the quality attributes and effectiveness of these nano-formulations. Therefore, the systematic drug development approach (QbD) and multivariate design and statistical analysis (DOE) can be very helpful and recommended for the optimization of the composition and production of RNA-LNPs. This review addresses the concepts and applications of QbD and/or DOE for the development of lipid nanoparticles for the delivery of different types of RNA, reporting examples published in the ten recent years presenting the latest trends and regulatory requirements as well as the modern mathematical and statistical design methods. As the topic explored in this review is a novel approach, the full QbD has been described in only a few papers, and a few refer only to some aspects of QbD. In contrast, the DOE approach has been used in most of the optimization works. Different approaches and innovations in DOE have been observed. Traditional statistical tests and modeling (ANOVA, regression analysis) are slowly being replaced by artificial intelligence and machine learning methods.
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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.