Biomedical Engineering Reference
In-Depth Information
3 Challenging Features of Ocular Toxicology
Ocular toxicology is a subspecialty of toxicology that not only
studies the effects of drugs on ocular tissue administered by the
traditional routes of drug delivery to the eye, namely topically,
periocularly, and intravitreally, but also is a study of the effect on
ocular tissue from nonspecific systemic exposure of drugs (general
toxicology) and the toxicologic effect of ocular devices and surgical
materials in the eye. The specialized field of the study of glaucoma
therapies and devices will be reviewed by Dr. Paul Miller in
Chapter
9
, while Dr. David Wilkie, in Chapter
8
, will be reviewing
the general ophthalmic examination as it pertains to general ocular
toxicology including species associated findings. Drs. Joseph Carr-
away and Elaine Daniel will provide details on study design and
methodologies for study of ocular medical devices in Chapter
10
.
Drs. Mike Robinson and Susan Lee will review the federal regu-
latory process regarding ocular pharmacology, pharmacokinetics,
pharmacodynamics, and toxicity of sustained-release ocular drug
delivery systems in Chapter
7
and Dr. Imran Ahmed will review the
chemistry, manufacturing, and control (CMC) for ocular medica-
tions in Chapter
4
.
Also important in the study of ocular pharmacology, pharma-
cokinetics, and toxicology is the bioanalysis of ocular tissues and
fluids, which will be reviewed in Chapter
3
by Drs. Poonam Vela-
galeti and Michael Buonarati, and the
absorption
,
distribution
,
metabolism
,
and
excretion
of drugs in ocular tissue, which will be
reviewed in Chapter
5
by Dr. Neels J. Van der Schyf and colleagues.
Histopathologic effects of ocular drugs, devices, and therapies will
be reviewed by Drs. Leandro Teixeira and James Render in
Chapter
11
.
4
Summary
The vision for this handbook is to provide ophthalmologists,
toxicologists, and pharmacologists with both an introduction to
the proper methods for ocular pharmacology and toxicology as
well as providing them with practical methodologies for conduct-
ing studies, including study design and specialized methodology
for ocular tissue. Proper design and conduct of these studies are
important because they evaluate the potential for ocular toxicity
or other adverse effects arising from the systemic, topical, or other
administration of drugs or compounds, the use of medical devices,
or certain surgical procedures. While in some cases the studies
are designed to provide proof of concept as regards therapeutic
efficacy, in the majority of cases studies are being conducted
specifically to enable an adequate assessment of safety of test
