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Intracellular Delivery III - Market Entry Barriers of Nanomedicines (Hardcover, 1st ed. 2016)
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Intracellular Delivery III - Market Entry Barriers of Nanomedicines (Hardcover, 1st ed. 2016)
Series: Fundamental Biomedical Technologies, 8
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A critical review is attempted to assess the status of nanomedicine
entry onto the market. The emergence of new potential therapeutic
entities such as DNA and RNA fragments requires that these new
"drugs" will need to be delivered in a cell-and organelle-specific
manner. Although efforts have been made over the last 50 years or
so to develop such delivery technology, no effective and above all
clinically approved protocol for cell-specific drug delivery in
humans exists as yet. Various particles, macromolecules, liposomes
and most recently "nanomaterials" have been said to "show promise"
but none of these promises have so far been "reduced" to human
clinical practice. The focus of this volume is on cancer indication
since the majority of published research relates to this
application; within that, we focus on solid tumors (solid
malignancies). Our aim is critically to evaluate whether
nanomaterials, both non-targeted and targeted to specific cells,
could be of therapeutic benefit in clinical practice. The emphasis
of this volume will be on pharmacokinetics (PK) and
pharmacodynamics (PD) in animal and human studies. Apart from the
case of exquisitely specific antibody-based drugs, the development
of target-specific drug-carrier delivery systems has not yet been
broadly successful at the clinical level. It can be argued that
drugs generated using the conventional means of drug development
(i.e., relying on facile biodistribution and activity after
(preferably) oral administration) are not suitable for a
target-specific delivery and would not benefit from such delivery
even when a seemingly perfect delivery system is available.
Therefore, successful development of site-selective drug delivery
systems will need to include not only the development of suitable
carriers, but also the development of drug entities that meet the
required PK/PD profile.
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