Volume 12, Issue 9

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September 2022

Regulatory Framework on Nanomedicine. Guest Editors: Kathleen Spring, Klaus-M. Weltring, Adriele Prina-Mello, and Ruth Schmid

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16 articles in this issue

REFINE special issue
Kathleen Spring
Klaus-M. Weltring
Ruth Schmid
Preface Open access 26 July 2022 Pages: 2039 - 2041
Regulatory safety evaluation of nanomedical products: key issues to refine
Wim H. De Jong
Robert E. Geertsma
Gerrit Borchard
Inspirational Note Open access 30 July 2022 Pages: 2042 - 2047
Three-dimensional (3D) liver cell models - a tool for bridging the gap between animal studies and clinical trials when screening liver accumulation and toxicity of nanobiomaterials
Melissa Anne Tutty
Dania Movia
Adriele Prina-Mello
Review Open access 04 May 2022 Pages: 2048 - 2074
Subcellular detection of PEBCA particles in macrophages: combining darkfield microscopy, confocal Raman microscopy, and ToF–SIMS analysis
Antje Vennemann
Daniel Breitenstein
Martin Wiemann
Original Article Open access 19 February 2022 Pages: 2075 - 2088
A multistep in vitro hemocompatibility testing protocol recapitulating the foreign body reaction to nanocarriers
Valeria Perugini
Ruth Schmid
Matteo Santin
Original Article Open access 22 March 2022 Pages: 2089 - 2100
A Decision Support System for preclinical assessment of nanomaterials in medical products: the REFINE DSS
Alex Zabeo
Fabio Rosada
Danail Hristozov
Original Article Open access 10 May 2022 Pages: 2101 - 2113
A comparative biodistribution study of polymeric and lipid-based nanoparticles
Andreas K. O. Åslund
Rob J. Vandebriel
Sven Even F. Borgos
Original Article Open access 15 April 2022 Pages: 2114 - 2131
Physiologically based pharmacokinetic modeling of intravenously administered nanoformulated substances
Jordi Minnema
Sven Even F. Borgos
Christiaan Delmaar
Original Article Open access 12 May 2022 Pages: 2132 - 2144
Future perspectives for advancing regulatory science of nanotechnology-enabled health products
Blanka Halamoda-Kenzaoui
Robert Geertsma
Susanne Bremer-Hoffmann
Original Article Open access 12 June 2022 Pages: 2145 - 2156
Pre-clinical 2D and 3D toxicity response to a panel of nanomaterials; comparative assessment of NBM-induced liver toxicity
Melissa Anne Tutty
Gabriele Vella
Adriele Prina-Mello
Original Article Open access 28 June 2022 Pages: 2157 - 2177
A physiologically based pharmacokinetic model to predict pegylated liposomal doxorubicin disposition in rats and human
Maiara Camotti Montanha
Alice Howarth
Marco Siccardi
Original Article 13 May 2022 Pages: 2178 - 2186
Standardization of an in vitro assay matrix to assess cytotoxicity of organic nanocarriers: a pilot interlaboratory comparison
Kai Moritz Eder
Anne Marzi
Jürgen Schnekenburger
Original Article Open access 06 July 2022 Pages: 2187 - 2206
Interlaboratory evaluation of a digital holographic microscopy–based assay for label-free in vitro cytotoxicity testing of polymeric nanocarriers
Anne Marzi
Kai Moritz Eder
Jürgen Schnekenburger
Original Article Open access 08 July 2022 Pages: 2207 - 2224
An inter-laboratory comparison of an NLRP3 inflammasome activation assay and dendritic cell maturation assay using a nanostructured lipid carrier and a polymeric nanomedicine, as exemplars
Rob J. Vandebriel
Christopher A. W. David
Neill J. Liptrott
Original Article Open access 15 July 2022 Pages: 2225 - 2242
Evaluating nanobiomaterial-induced DNA strand breaks using the alkaline comet assay
Melissa Anne Tutty
Gabriele Vella
Adriele Prina-Mello
Original Article Open access 25 May 2022 Pages: 2243 - 2258
Correction: Evaluating nanobiomaterial-induced DNA strand breaks using the alkaline comet assay
Melissa Anne Tutty
Gabriele Vella
Adriele Prina-Mello
Correction Open access 19 June 2022 Pages: 2259 - 2259

Volume 12, Issue 9

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