Product quality for nanomaterials: current U.S. experience and perspective

Tyner, Katherine M.; Zou, Peng; Yang, Xiaochuan; Zhang, Hailing; Cruz, Celia N.; Lee, Sau L.

doi:10.1002/wnan.1338

Cited by 56 publications

(38 citation statements)

References 56 publications

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“…Particle size is a frequently requested characteristic when discussing nanomaterials 9 . It has been repeatedly demonstrated that the size of nanomaterials can impact absorption, biodistribution and excretion [38][39][40] .…”

Section: Particle Size Distributionmentioning

confidence: 99%

“…Such diversity is a result of both the evolving nature of the field as well as the method used to obtain the data. For example, a D50 value could be supplied for data arising from laser diffraction, whereas a Z ave value would be supplied for data arising from DLS, or a mean for the apparent diameter for electron microscopy data 9 .…”

Section: Particle Size Distributionmentioning

confidence: 99%

“…However, unique properties that arise from the small size and large surface area of nanomaterials may lead to specific scientific considerations for physicochemical testing and manufacturing controls when following the current CDER guidelines [6][7][8] . A review by Tyner et al has discussed key aspects of these scientific considerations based on CDER's experience with drug products containing nanomaterials 9 .…”

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confidence: 99%

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The evolving landscape of drug products containing nanomaterials in the United States

et al. 2017

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The Center for Drug Evaluation and Research (CDER) within the US Food and Drug Administration (FDA) is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitted to CDER. In this Analysis, data from more than 350 products show an increase in the submissions of drug products containing nanomaterials over the last two decades. Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug applications, with the largest class of products being liposomal formulations intended for cancer treatments. Approximately 80% of products have average particle sizes of 300 nm or lower. This analysis identifies several trends in the development of drug products containing nanomaterials, including the relative rate of approvals of these products, and provides a comprehensive overview on the landscape of nanotechnology application in medicine.

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Section: Particle Size Distributionmentioning

confidence: 99%

Section: Particle Size Distributionmentioning

confidence: 99%

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confidence: 99%

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The evolving landscape of drug products containing nanomaterials in the United States

et al. 2017

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“…Applying this or a similar approach in preclinical studies helps to obtain reproducible drug batches [18][19][20]. …”

Section: Chemical Chemical and Microbiological Aspects Such As Macmentioning

confidence: 99%

Introductory Chapter: Reduce the Gap from Bench to Bedside for Nanomedicines Increasing the Stability to Long-Term Storage

Musumeci¹,

Pignatello²

2018

Biomaterials - Physics and Chemistry - New Edition

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“…Studies at this stage may be the first tests of a drug product's translational potential and will provide a foundation for further preclinical development, to eventually include tests geared at meeting regulatory requirements for an Investigational New Drug (IND) application (4).…”

Section: Introductionmentioning

confidence: 99%

Early Development Challenges for Drug Products Containing Nanomaterials

Grossman

Crist

Clogston

2016

AAPS J

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The vast majority of drug product candidates in early development fail to progress to clinics. This is true for products containing nanomaterials just as for other types of pharmaceuticals. Early development pathways should therefore place high priority on experiments that help candidates fail faster and less expensively. Nanomedicines fail for many reasons, but some are more avoidable than others. Some of the points of failure are not considerations in the development of small molecules or biopharmaceuticals, and so may be unexpected, even to those with previous experience bringing drug products to the clinic. This article reviews experiments that have proven useful in providing "go/no-go" decision-making data for nanomedicines in early preclinical development. Of course, the specifics depend on the particulars of the drug product and the nanomaterial type, and not every product shares the same development pathway or the same potential points of failure. Here, we focus on challenges that differ from those in the development of traditional small molecule therapeutics, and on experiments that reveal deficiencies that can only be corrected by essentially starting over-altering the nanomedicine to an extent that all previous characterization and proof-of-concept testing must be repeated. Conducting these experiments early in the development process can save significant resources and time and allow developers to focus on derisked candidates with a greater likelihood of ultimate success.

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Product quality for nanomaterials: current U.S. experience and perspective

Cited by 56 publications

References 56 publications

The evolving landscape of drug products containing nanomaterials in the United States

The evolving landscape of drug products containing nanomaterials in the United States

Introductory Chapter: Reduce the Gap from Bench to Bedside for Nanomedicines Increasing the Stability to Long-Term Storage

Early Development Challenges for Drug Products Containing Nanomaterials

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