Nanoparticle-based drug delivery systems: a commercial and regulatory outlook as the field matures

No abstract is available for this paper.

• Publication year

  2017

• Venue

  Expert Opinion on Drug Delivery

• Publication date

  2017-07-01

• Fields of study

  Medicine, Materials Science, Computer Science

• Identifiers
  DOI 10.1080/17425247.2016.1244187PMID 27730820
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Building the Design

  2018cited by this paper
• Challenges and strategies in anti-cancer nanomedicine development: An industry perspective.

  2017cited by this paper
• Delivery of siRNA targeting tumor metabolism using non-covalent PEGylated chitosan nanoparticles: Identification of an optimal combination of ligand structure, linker and grafting method.

  2016cited by this paper
• Critical questions in development of targeted nanoparticle therapeutics

  2016cited by this paper
• Emerging Frontiers in Drug Delivery

  2016cited by this paper
• Emerging Frontiers in Drug Delivery.

  2016cited by this paper
• Building the design, translation and development principles of polymeric nanomedicines using the case of clinically advanced poly(lactide(glycolide))-poly(ethylene glycol) nanotechnology as a model: An industrial viewpoint.

  2016cited by this paper
• Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date

  2016cited by this paper
• Critical questions in development of targeted nanoparticle therapeutics

  2016cited by this paper
• Key cost drivers of pharmaceutical clinical trials in the United States

  2016cited by this paper
• Visualizing lipid-formulated siRNA release from endosomes and target gene knockdown

  2015cited by this paper
• Liposomes: The Science and the Regulatory Landscape

  2015cited by this paper
• Intracellular siRNA delivery dynamics of integrin-targeted, PEGylated chitosan-poly(ethylene imine) hybrid nanoparticles: A mechanistic insight.

  2015cited by this paper
• Nanomedicine: Science, Business, and Impact

  2015cited by this paper
• Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

  2015cited by this paper
• Regulatory aspects on nanomedicines.

  2015cited by this paper
• The similarity question for biologicals and non-biological complex drugs.

  2015cited by this paper
• Progress in material design for biomedical applications

  2015cited by this paper
• Challenges facing sterilization and depyrogenation of nanoparticles: effects on structural stability and biomedical applications.

  2014cited by this paper
• Nanomedicines for Cancer Therapy : An Update of FDA Approved and Those under Various Stages of Development

  2014cited by this paper
• EPR: Evidence and fallacy.

  2014cited by this paper
• Complexity in the therapeutic delivery of RNAi medicines: an analytical challenge

  2014cited by this paper
• Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework

  2014cited by this paper
• The use of theranostic gadolinium-based nanoprobes to improve radiotherapy efficacy

  2014cited by this paper
• Cancer nanotechnology: the impact of passive and active targeting in the era of modern cancer biology.

  2014cited by this paper
• Non-viral vectors for gene-based therapy

  2014cited by this paper
• Market Considerations for Nanomedicines and Theranostic Nanomedicines

  2014cited by this paper
• Nanotherapeutics in the EU: an overview on current state and future directions

  2014cited by this paper
• Journal of Pharmaceutical Sciences and Pharmacology: A New Perspective

  2014cited by this paper
• How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

  2013cited by this paper
• Delivery materials for siRNA therapeutics.

  2013cited by this paper
• Understanding the correlation between in vitro and in vivo immunotoxicity tests for nanomedicines.

  2013cited by this paper
• Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines.

  2013cited by this paper
• Cancer nanomedicines: so many papers and so few drugs!

  2013cited by this paper
• Trial Watch: Phase II and Phase III attrition rates 2011–2012

  2013cited by this paper
• The big picture on nanomedicine: the state of investigational and approved nanomedicine products.

  2013cited by this paper
• Nanoscale radiotherapy with hafnium oxide nanoparticles.

  2012cited by this paper
• Scientific considerations for complex drugs in light of established and emerging regulatory guidance

  2012cited by this paper
• Tolerability, safety, pharmacokinetics, and efficacy of doxorubicin-loaded anti-EGFR immunoliposomes in advanced solid tumours: a phase 1 dose-escalation study.

  2012cited by this paper
• Tuning nanoparticle uptake: live-cell imaging reveals two distinct endocytosis mechanisms mediated by natural and artificial EGFR targeting ligand.

  2012cited by this paper
• Doxil®--the first FDA-approved nano-drug: lessons learned.

  2012cited by this paper
• α(V)β(3) integrin-targeted PLGA-PEG nanoparticles for enhanced anti-tumor efficacy of a Pt(IV) prodrug.

  2012cited by this paper
• Preclinical Development and Clinical Translation of a PSMA-Targeted Docetaxel Nanoparticle with a Differentiated Pharmacological Profile

  2012cited by this paper
• Characterization of PEGylated nanoliposomes co-remotely loaded with topotecan and vincristine: relating structure and pharmacokinetics to therapeutic efficacy.

  2012cited by this paper
• Targeted polymeric therapeutic nanoparticles: design, development and clinical translation.

  2012cited by this paper
• Challenges in Development of Nanoparticle-Based Therapeutics

  2012influential reference
• Nanomedicine in cancer therapy: Innovative trends and prospects

  2011cited by this paper
• In vitro and in vivo characterizations of PEGylated liposomal doxorubicin.

  2011cited by this paper
• Nanoparticle therapeutics: FDA approval, clinical trials, regulatory pathways, and case study.

  2011cited by this paper
• Activation of complement by therapeutic liposomes and other lipid excipient-based therapeutic products: prediction and prevention.

  2011cited by this paper
• The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee

  2010cited by this paper
• Strategies in the design of nanoparticles for therapeutic applications

  2010cited by this paper
• To exploit the tumor microenvironment: Passive and active tumor targeting of nanocarriers for anti-cancer drug delivery.

  2010cited by this paper
• Dose Escalation Methods in Phase I Cancer Clinical Trials

  2009cited by this paper
• Targeting of tumor endothelium by RGD-grafted PLGA-nanoparticles loaded with paclitaxel.

  2009cited by this paper
• Development of lipidoid-siRNA formulations for systemic delivery to the liver.

  2009cited by this paper
• Methods for the Preparation and Manufacture of Polymeric Nanoparticles

  2009cited by this paper
• Impact of nanotechnology on drug delivery.

  2009cited by this paper
• Quality by design for biopharmaceuticals

  2009influential reference
• Randomized Crossover Pharmacokinetic Study of Solvent-Based Paclitaxel and nab-Paclitaxel

  2008cited by this paper
• Clinical pharmacology of liposomal anthracyclines: focus on pegylated liposomal Doxorubicin.

  2008cited by this paper
• Nab-paclitaxel for breast cancer: a new formulation with an improved safety profile and greater efficacy

  2007cited by this paper
• Exploiting lymphatic transport and complement activation in nanoparticle vaccines

  2007cited by this paper
• The emerging nanomedicine landscape

  2006cited by this paper
• Tumor vascular permeability, accumulation, and penetration of macromolecular drug carriers.

  2006cited by this paper
• Comparative Preclinical and Clinical Pharmacokinetics of a Cremophor-Free, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Paclitaxel Formulated in Cremophor (Taxol)

  2005cited by this paper
• Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity.

  2005cited by this paper
• Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan.

  2001cited by this paper
• Dynamic optimization of hybridoma growth in a fed-batch bioreactor.

  2000cited by this paper
• Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes.

  1994cited by this paper
• Large unilamellar liposomes with low uptake into the reticuloendothelial system

  1987cited by this paper
• pH-sensitive liposomes: possible clinical implications.

  1980cited by this paper
• Diffusion of univalent ions across the lamellae of swollen phospholipids.

  1965cited by this paper
• Annals of the New York Academy of Sciences Nanomedicines: Addressing the Scientific and Regulatory Gap

  year unknowncited by this paper

• Bridging Gaps in Fungal Keratitis Management: Novel Diagnostics, Drug Delivery Systems, and Gene Therapies

  2026cites this paper
• Systematic review of nanoelectronic drug delivery systems advancing technological innovation, clinical integration, and personalized therapy

  2026cites this paper
• Ligand-Functionalized Core–Shell Nanoparticles for Precision Therapy of Luminal A Breast Cancer: Emerging Strategies, Clinical Challenges, and Future Perspectives

  2026cites this paper
• Exploration of Inhalable Nanoparticles for Lung Cancer Therapy: Advances, Challenges, and Future Perspectives

  2026cites this paper
• Nanomedicine as a Promising Treatment Approach for Obesity

  2025cites this paper
• Emu Oil‐Based Nanocarriers: A Versatile and Biocompatible Platform for Targeted Drug Delivery and Regenerative Medicine

  2025cites this paper
• Nanoparticle-based strategy in CAR-T cell immunotherapy: challenges, implications, and perspectives

  2025cites this paper
• Improving extracellular matrix penetration with biocatalytic metal-organic framework nanoswimmers.

  2025cites this paper
• Insight into the Recent Developments of Nanoparticles in Treatment of Cancer and Neuro-Degenerative Disease: A Review.

  2025cites this paper
• Advanced oral drug delivery systems for gastrointestinal targeted delivery: the design principles and foundations

  2025cites this paper
• Recent Advances in Nanomedicine

  2025cites this paper
• Interactions of nanoparticles with living and synthetic bio-membrane.

  2025cites this paper
• An Explicative Review on Nanotechnology-based Drug Delivery Systems for Alleviating Oxidative Stress-driven Pathologies.

  2025cites this paper
• Delving Into Nanoparticle Systems for Enhanced Drug Delivery Technologies

  2025cites this paper
• LAP-Hsp60 complex modulates epithelial tight junction barrier

  2025cites this paper
• Exploring the therapeutic potential of ligand-decorated nanostructured lipid carriers for targeted solid tumor therapy.

  2025cites this paper
• Natural Molecule-Based Nanoparticles: A Minimalist Approach to Treating Acute Lung Injury

  2025cites this paper
• Advancing glaucoma treatment with nanotechnology: a new frontier in ophthalmology.

  2025cites this paper
• New Nanobioceramics Based on Hydroxyapatite for Biomedical Applications: Stability and Properties

  2025cites this paper
• Evolution of Theranostic Nanoparticles Through the Lens of Patents

  2025cites this paper
• Recent Development of Nanoparticle Platforms for Organophosphate Nerve Agent Detoxification

  2025cites this paper
• Scaling nanopharmaceutical production for personalized medicine: challenges and strategies

  2025cites this paper
• Explicit analysis of in vivo, meterological and statistical hurdles in successful clinical translation of targeted nanomedicines and plausible remedial strategies

  2025cites this paper
• A Comprehensive Review of Nanoparticle-Based Drug Delivery for Modulating PI3K/AKT/mTOR-Mediated Autophagy in Cancer

  2025cites this paper
• Nanocarriers for the delivery of the CRISPR/Cas9 system.

  2025cites this paper
• Progress in peptide and protein therapeutics: Challenges and strategies

  2025cites this paper
• Computational fluid dynamics modeling and simulation of nanoparticle-tumor interaction: Systematic literature review

  2025cites this paper
• Upconverting Nanoparticle‐Loaded Microneedles for Near‐Infrared Responsive Delivery of Gonadotropins to Increase Success of In Vitro Fertilization

  2025cites this paper
• Innovative nanoparticle-based therapies for pancreatic neuroendocrine tumours (PNETs): advances, challenges, and future directions

  2025cites this paper
• Healthcare and cutting-edge technology: Advancements, challenges, and future prospects

  2025cites this paper
• Inhalable Nanomaterial Discoveries for Lung Cancer Therapy: A Review

  2025cites this paper
• Chlorhexidine-Loaded Zinc Nanoparticles: A Potent Antibacterial Agent Against Streptococcus pneumoniae

  2025cites this paper
• Cyclodextrin-based therapeutics delivery systems: A review of current clinical trials

  2025cites this paper
• Revolutionizing mRNA Vaccines Through Innovative Formulation and Delivery Strategies

  2025cites this paper
• Efficacy of Nanoparticle-based Localised Immunomodulation to Reduce Graft-versus-host Disease in Murine Model of Bone Marrow Transplantation: A Systematic Review

  2025cites this paper
• Nanotechnological innovations in paediatric tuberculosis management: current trends and future prospects

  2024cites this paper
• Production of 5-fluorouracil-loaded PLGA nanoparticles with toroidal microfluidic system and optimization of process variables by design of experiments.

  2024cites this paper
• Beyond the adverse effects of the systemic route: Exploiting nanocarriers for the topical treatment of skin cancers.

  2024cites this paper
• Unlocking the Potential of RNA Nanoparticles: A Breakthrough Approach to Overcoming Challenges in Colon Cancer Treatment.

  2024cites this paper
• Light-responsive polymeric nanoparticles for retinal drug delivery: design cues, challenges and future perspectives

  2024cites this paper
• Naringenin Nanoformulations for Neurodegenerative Diseases.

  2024cites this paper
• Nanomaterial-enabled drug transport systems: a comprehensive exploration of current developments and future avenues in therapeutic delivery

  2024cites this paper
• CAR T Cell Nanosymbionts: Revealing the Boundless Potential of a New Dyad

  2024cites this paper
• Targeting the undruggable in glioblastoma using nano-based intracellular drug delivery

  2024cites this paper
• Silver and Iron Nanoparticles: Green Synthesis and Characterization.

  2024cites this paper
• Phosphorene: A novel nanomaterial revolutionizing biomedicine

  2024cites this paper
• Design and Development of Solid Lipid Nanoparticles of Tofacitinib Citrate for the Treatment of Rheumatoid Arthritis: A Quality by Design Approach.

  2024cites this paper
• The Role of Nanomaterials in Diagnosis and Targeted Drug Delivery

  2024cites this paper
• Polypept(o)ides – Origins, Synthesis, Applications and Future Directions

  2024cites this paper
• Clinical applications and therapeutic potentials of advanced nanoparticles: a comprehensive review on completed human clinical trials

  2024cites this paper
• Current status of nanoparticle-mediated immunogenic cell death in cancer immunotherapy.

  2024cites this paper
• Polyester nanoparticles delivering chemotherapeutics: Learning from the past and looking to the future to enhance their clinical impact in tumor therapy

  2024cites this paper
• Exploring the underlying modes of organic nanoparticles in diagnosis, prevention, and treatment of cancer: a review from drug delivery to toxicity

  2024cites this paper
• Biomaterials functionalized with magnetic nanoparticles for tissue engineering: Between advantages and challenges

  2024cites this paper
• Delivery of rapamycin by biomimetic peptide nanoparticles targeting oxidized low-density lipoprotein in atherosclerotic plaques.

  2024cites this paper
• Transformative Impact of Nanocarrier‐Mediated Drug Delivery: Overcoming Biological Barriers and Expanding Therapeutic Horizons

  2024cites this paper
• Receptor-Assisted Nanotherapeutics for Overcoming the Blood–Brain Barrier

  2024cites this paper
• Covalent organic frameworks (COFs) as carrier for improved drug delivery and biosensing applications

  2024cites this paper
• Layered Double Hydroxides: Recent Progress and Promising Perspectives Toward Biomedical Applications

  2024cites this paper
• Nanoparticle-Mediated Cell Delivery: Advancements in Corneal Endothelial Regeneration

  2024cites this paper
• Intraocular drug delivery systems for Diabetic retinopathy: Current and future prospective

  2024cites this paper
• Mechanisms, Applications, and Challenges of Utilizing Nanomaterials in Cryopreservation

  2024cites this paper
• Advancements in Drug Delivery Systems for the Treatment of Sarcopenia: An Updated Overview

  2024cites this paper
• Innovative lipid nanoparticles: A cutting-edge approach for potential renal cell carcinoma therapeutics.

  2024cites this paper
• Current status and prospects for improved targeted delivery approaches for cancer.

  2023cites this paper
• Biopolymers in Drug and Gene Delivery Systems 2.0

  2023cites this paper
• Recent advances of polymeric nanoplatforms for cancer treatment: smart delivery systems (SDS), nanotheranostics and multidrug resistance (MDR) inhibition

  2023cites this paper
• Multistage Self-Assembled Nanomaterials for Cancer Immunotherapy

  2023cites this paper
• Addressing the intersection of COVID-19 and metal nanoparticle use: Risks and control strategies

  2023cites this paper
• Emerging platinum(IV) prodrug nanotherapeutics: A new epoch for platinum-based cancer therapy.

  2023cites this paper
• Fluorescence Lifetime Nanoscopy of Liposomal Irinotecan Onivyde: From Manufacturing to Intracellular Processing

  2023cites this paper
• Quantitative size-resolved characterization of mRNA nanoparticles by in-line coupling of asymmetrical-flow field-flow fractionation with small angle X-ray scattering

  2023cites this paper
• Natural Polymeric Nanobiocomposites for Anti-Cancer Drug Delivery Therapeutics: A Recent Update

  2023cites this paper
• Research Progress of Nanomaterials in Chemotherapy of Osteosarcoma

  2023cites this paper
• Scalable production of microscopic particles for biological delivery

  2023cites this paper
• Nano-dimensional gold synthesis for biomedical applications: upscaling and challenges

  2023cites this paper
• Biomedical applications of PLGA nanoparticles in nanomedicine: advances in drug delivery systems and cancer therapy

  2023cites this paper
• Light and pH responsive catanionic vesicles based on a chalcone/flavylium photoswitch for smart drug delivery: From molecular design to the controlled release of doxorubicin.

  2023cites this paper
• Polymer- and Lipid-Based Nanocarriers for Ocular Drug Delivery: Current Status and Future Perspectives.

  2023cites this paper
• PEGylated and functionalized polylactide-based nanocapsules: an overview.

  2023cites this paper
• Combining orthogonal measurements to unveil diclofenac encapsulation into polymeric and lipid nanocarriers.

  2023cites this paper
• An emerging era in manufacturing of drug delivery systems: Nanofabrication techniques

  2023cites this paper
• Targeting anticancer immunity in oral cancer: Drugs, products, and nanoparticles.

  2023cites this paper
• Nanoparticles: Taking a Unique Position in Medicine

  2023cites this paper
• Nanoparticle-Based Drug Delivery Systems: Advances and Challenges in Nanomedicine

  2023cites this paper
• Current Advances in Lipid Nanosystems Intended for Topical and Transdermal Drug Delivery Applications

  2023cites this paper
• Recent Advances in RNA Therapy and Its Carriers to Treat the Single-Gene Neurological Disorders

  2022cites this paper
• Progress in drug-delivery systems in cardiovascular applications: stents, balloons and nanoencapsulation.

  2022cites this paper
• Protein Nanoparticles: Uniting the Power of Proteins with Engineering Design Approaches

  2022cites this paper
• Cell membrane-coated nanoparticles: a novel multifunctional biomimetic drug delivery system

  2022cites this paper
• Cytokine Therapy Combined with Nanomaterials Participates in Cancer Immunotherapy

  2022cites this paper
• The Association of Patent Ductus Arteriosus with Inflammation: A Narrative Review of the Role of Inflammatory Biomarkers and Treatment Strategy in Premature Infants

  2022cites this paper
• Applications and prospects of intra-articular drug delivery system in arthritis therapeutics.

  2022cites this paper
• Rapamycin incorporating hydrogel improves the progression of osteoarthritis by inducing synovial macrophages polarization and reducing intra-articular inflammation

  2022cites this paper
• Antibiotic delivery from bone-targeted mesoporous silica nanoparticles for the treatment of osteomyelitis caused by methicillin-resistant Staphylococcus aureus.

  2022cites this paper
• A Nanomedicine Structure-Activity Framework for Research, Development, and Regulation of Future Cancer Therapies.

  2022cites this paper
• Bench-to-bedside: Feasibility of nano-engineered and drug-delivery biomaterials for bone-anchored implants and periodontal applications

  2022cites this paper
• Toxicity of metal-based nanoparticles: Challenges in the nano era

  2022cites this paper
• Solvent Controls Nanoparticle Size during Nanoprecipitation by Limiting Block Copolymer Assembly

  2022cites this paper
• The Potential of Curcumin-Capped Nanoparticle Synthesis in Cancer Therapy: A Green Synthesis Approach

  2022cites this paper