Evaluating Plasma Pharmacokinetics of Intravenous Iron Formulations: Judging Books by Their Covers?

Pai, Amy Barton

doi:10.1007/s40262-014-0218-2

Cited by 5 publications

(3 citation statements)

References 8 publications

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“…Additionally, characterizing the in vivo behavior of nanomedicines is exceedingly challenging. As nanomedicines are designed to target specific tissues and cell types, plasma pharmacokinetics traditionally used in drug evaluation may not accurately describe tissue biodistribution, especially over a long time [23,24]. Moreover, conventional quantification methods do not accurately measure the circulating fraction of the drug bound to blood cells.…”

Section: Challenges In Regulatory Evaluation Of Nanomedicinesmentioning

confidence: 99%

“…Moreover, conventional quantification methods do not accurately measure the circulating fraction of the drug bound to blood cells. Few assays can distinguish the free drug from the encapsulated drug, and target tissue deposition, biodegradation, and subsequent bioavailability may vary over several weeks [23,24]. The US-FDA identified eleven factors that constitute unique considerations and are fundamentally critical to the risk-based evaluation of drug products containing nanomaterials (Table 1) [6].…”

Section: Challenges In Regulatory Evaluation Of Nanomedicinesmentioning

confidence: 99%

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Need for Expansion of Pharmacy Education Globally for the Growing Field of Nanomedicine

et al. 2022

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The emerging landscape of nanomedicine includes a wide variety of active pharmaceutical ingredients and drug formulations. Their design provides nanomedicines with unique features leading to improved pharmacokinetics and pharmacodynamics. They are manufactured using conventional or biotechnological manufacturing processes. Their physical characteristics are vastly different from traditional small-molecule drugs. Pharmacists are important members of the multi-disciplinary team of scientists involved in their development and clinical application. Consequently, their training should lead to an understanding of the complexities associated with the production and evaluation of nanomedicines. Therefore, student pharmacists, post-doctoral researchers, and trainees should be given more exposure to this rapidly evolving class of therapeutics. This commentary will provide an overview of nanomedicine education within the selection of pharmacy programs globally, discuss the current regulatory challenges, and describe different approaches to incorporate nanomedicine science in pharmacy programs around the world.

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Section: Challenges In Regulatory Evaluation Of Nanomedicinesmentioning

confidence: 99%

Section: Challenges In Regulatory Evaluation Of Nanomedicinesmentioning

confidence: 99%

Need for Expansion of Pharmacy Education Globally for the Growing Field of Nanomedicine

et al. 2022

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“…14,15 Because nanomedicines are designed to target specific tissues and cell types, simple plasma PK profiles may not accurately predict the biodistribution profiles. 16 Additionally, there are few assays that can distinguish the free from encapsulated active drug. 17 All of these factors naturally extend from the approval of a new nanomedicines to the evaluation and approval process for generic and follow-on copies of nanomedicines.…”

Section: Types Of Nanomedicinesmentioning

confidence: 99%

The Growing Field of Nanomedicine and Its Relevance to Pharmacy Curricula

Weissig

Elbayoumi

Flühmann

et al. 2021

American Journal of Pharmaceutical Education

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The field of nanomedicine is a rapidly growing scientific domain. Nanomedicine encompasses a diverse number of active pharmaceutical ingredients. Submissions of Investigational New Drugs and New Drug Applications have risen dramatically over the last decade. Currently, there are over 50 FDA approved nanomedicines on the US market. Thus, because of the fundamental role pharmacists will play in therapeutic and administrative decisions regarding nanomedicines, it is imperative that they gain exposure to this rapidly evolving class of drugs. This commentary will describe nanomedicines, discuss current regulatory challenges, and provide recommendations for judicious incorporation of nanomedicine topics into the Doctor of Pharmacy curriculum based on emerging pharmaceutical and clinical science applications.

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Tissue biodistribution of intravenous iron-carbohydrate nanomedicines differs between preparations with varying physicochemical characteristics in an anemic rat model

Funk

Weber²,

Nyffenegger

et al. 2022

European Journal of Pharmaceutics and Biopharmaceutics

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Evaluating Plasma Pharmacokinetics of Intravenous Iron Formulations: Judging Books by Their Covers?

Cited by 5 publications

References 8 publications

Need for Expansion of Pharmacy Education Globally for the Growing Field of Nanomedicine

Need for Expansion of Pharmacy Education Globally for the Growing Field of Nanomedicine

The Growing Field of Nanomedicine and Its Relevance to Pharmacy Curricula

Tissue biodistribution of intravenous iron-carbohydrate nanomedicines differs between preparations with varying physicochemical characteristics in an anemic rat model

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