Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars

Nanomedicines: addressing the scientific and regulatory gap

(2014) Sally Tinkle et al.   Annals of the New York Academy of Sciences

State-of-the-art in design rules for drug delivery platforms: Lessons learned from FDA-approved nanomedicines

(2014) Charlene M. Dawidczyk et al.   JOURNAL OF CONTROLLED RELEASE

Nanotoxicity: Oxidative Stress Mediated Toxicity of Metal and Metal Oxide Nanoparticles

(2014) Abhijit Sarkar et al.   JOURNAL OF NANOSCIENCE AND NANOTECHNOLOGY

Nanotherapeutics—Product Development Along the “Nanomaterial” Discussion

(2014) Matthias G. Wacker   JOURNAL OF PHARMACEUTICAL SCIENCES

Different Pharmaceutical Products Need Similar Terminology

(2013) Daan J. A. Crommelin et al.   AAPS Journal

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

(2013) Huub Schellekens et al.   AAPS Journal

Particle-size-dependent toxicity and immunogenic activity of mesoporous silica-based adjuvants for tumor immunotherapy

(2013) Xiupeng Wang et al.   Acta Biomaterialia

Workshop on the challenges in substitution of nonbiological complex drugs

(2013) V. P. Shah et al.   AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

Nanotechnology in Agri-Food Sector

(2013) Avnesh Kumari et al.   CRITICAL REVIEWS IN FOOD SCIENCE AND NUTRITION

The complex interplay of iron metabolism, reactive oxygen species, and reactive nitrogen species: Insights into the potential of various iron therapies to induce oxidative and nitrosative stress

(2013) Taija S. Koskenkorva-Frank et al.   FREE RADICAL BIOLOGY AND MEDICINE

Nanoparticles and the blood coagulation system. Part I: benefits of nanotechnology

(2013) Anna N Ilinskaya et al.   Nanomedicine

Next-generation nanomedicines and nanosimilars: EU regulators’ initiatives relating to the development and evaluation of nanomedicines

(2013) Falk Ehmann et al.   Nanomedicine

How Bio-questionable are the Different Recombinant Human Erythropoietin Copy Products in Thailand?

(2013) Liem Andhyk Halim et al.   PHARMACEUTICAL RESEARCH

Challenges in Development of Nanoparticle-Based Therapeutics

(2012) Neil Desai   AAPS Journal

Scientific considerations for complex drugs in light of established and emerging regulatory guidance

(2012) Chris Holloway et al.   Annals of the New York Academy of Sciences

Toxicity of TiO2 nanoparticles to cladocerans, algae, rotifers and plants – Effects of size and crystalline structure

(2012) Laura Clément et al.   CHEMOSPHERE

Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients

(2012) Eun Sil Lee et al.   CURRENT MEDICAL RESEARCH AND OPINION

Safety assessment of nanomaterials: Implications for nanomedicine

(2012) Andreas M. Nyström et al.   JOURNAL OF CONTROLLED RELEASE

Relating nanomaterial properties and microbial toxicity

(2012) Anil K. Suresh et al.   Nanoscale

Nanotechnology in Cancer Medicine

(2012) Jennifer H. Grossman et al.   PHYSICS TODAY

The Relationship between Fenestrations, Sieve Plates and Rafts in Liver Sinusoidal Endothelial Cells

(2012) Dmitri Svistounov et al.   PLoS One

Nanoparticle iron medicinal products – Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies

(2012) Gerrit Borchard et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Long term in vivo biotransformation of iron oxide nanoparticles

(2011) Michael Levy et al.   BIOMATERIALS

Assessing the In Vitro and In Vivo Toxicity of Superparamagnetic Iron Oxide Nanoparticles

(2011) Morteza Mahmoudi et al.   CHEMICAL REVIEWS

Effects of intravenous iron on mononuclear cells during the haemodialysis session

(2011) A. Martin-Malo et al.   NEPHROLOGY DIALYSIS TRANSPLANTATION

Do two intravenous iron sucrose preparations have the same efficacy?

(2011) J. Rottembourg et al.   NEPHROLOGY DIALYSIS TRANSPLANTATION

Use of parenteral iron products and serious anaphylactic-type reactions

(2010) Diane K. Wysowski et al.   AMERICAN JOURNAL OF HEMATOLOGY

Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin products?

(2010) Rao N. V. S. Mamidi et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

The therapeutic equivalence of complex drugs

(2010) Huub Schellekens et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Biodistribution and toxicity of intravenously administered silica nanoparticles in mice

(2009) Guangping Xie et al.   ARCHIVES OF TOXICOLOGY

Do Nanomedicines Require Novel Safety Assessments to Ensure their Safety for Long-Term Human Use?

(2009) Peter Hoet et al.   DRUG SAFETY

Minireview: Nanoparticles and the Immune System

(2009) Banu S. Zolnik et al.   ENDOCRINOLOGY

Emerging trends of nanomedicine - an overview

(2009) Selvarajan Sandhiya et al.   FUNDAMENTAL & CLINICAL PHARMACOLOGY