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Without a reliable translational assay tool kit for pharmacology and toxicology, the drug development process is costly and inefficient in taking initial in vitro cell-based screens to in vivo testing and subsequent clinical approvals.
Successful studies using animal models of PDT are blazing the trail for tomorrow's clinical approvals.
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Nevertheless, when they first received clinical approval, 26 years ago, they were hailed as a medical miracle.
Now retinal implants are at a similar point, as the first such device is about to be granted clinical approval in Europe and will then go on sale.The device, called the Argus II, is by no means a cure for blindness, says Robert Greenberg, the chief executive and co-founder of Second Sight, the company in Sylmar, California, that developed it.
Comparable to clinical approval by the European Medicines Agency or the U.S. Food and Drug Administration, reimbursement approval is very restricted.
Surface hydration enabled the liposome-encapsulated cancer drug doxorubicin (Doxil) to gain clinical approval in 1995.
First generation nanomedicines have received widespread clinical approval over the past two decades, from Doxil® (liposomal doxorubicin) in 1995 to Onivyde® (liposomal irinotecan) in 2015.
Much effort has been focused on the development of EGFR-directed antibody-based therapeutics, culminating in the clinical approval of the drugs cetuximab and panitumumab.
Photodynamic therapy (PDT) has clinical approval for use as a minimally invasive therapeutic procedure that is able to exert selective cytotoxic activity toward malignant cells.
But it urged federations to notify athletes "as soon as possible" as the drug did not have, and would not get, clinical approval.
It is an attractive approach to find new uses for old drugs as they have already been through extensive clinical testing and could easily be accelerated for clinical approval.
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CEO of Professional Science Editing for Scientists @ prosciediting.com