Biomedical Engineering Reference
In-Depth Information
physiology, reproductive biology, central nervous system,
and cardiovascular diseases; husbandry, handling, experi-
mental methodology, and management of primate colonies
and laboratories; primate wildlife management; and
behavior and sociology as related to medical conditions and
captive primate needs.
The
620, detail the use of certain species of nonhuman primates
for the production and safety testing of inactivated as well
as live poliomyelitis vaccine and measles, rubella, and
mumps vaccines. Rhesus monkeys are routinely used for
neurovirulence testing of modified live poliovirus vaccine,
although the regulations only specify the use of Macaca
spp. Species permissible as sources of kidney tissue culture
are Macaca or Cercopithecus spp. The cynomolgus or
rhesus monkey must be used for kidney tissue cultures in
adenovirus vaccine testing. For measles, rubella, and
mumps vaccines, the regulation requires the use of Macaca
or Ceropithecus spp. for neurovirulence testing. The FDA
Commissioner has the authority to select other primate
species for these tests if they are equally suitable and meet
all necessary requirements for testing.
International
Journal
of
Primatology
(
http://www.springer.com/life
þ
sciences/evolutionary
þ
%
26
biology/journal/10764
)istheofficial
journal of the International Primatological Society and is
a multidisciplinary forum devoted to current research in
fundamental primatology including anthropology,
anatomy, ethology, paleontology, psychology, sociology,
and zoology.
Primate Report
þ
developmental
þ
52
)s
a journal produced by the German Primate Center, with
a particular focus on the activities of the Center.
(
http://dpz.eu/index.php?id
¼
HUMAN AND ANIMAL DISEASE
CONTROL
The close relationship between nonhuman and human
primates means that disease consideration extends from
species-specific to interspecific concerns to ensure both
animal and human health.
GOOD LABORATORY AND
MANUFACTURING PRACTICE
The use of nonhuman primates is required in regulated
preclinical studies and in pharmaceutical, particularly
biological, production.
World Organization for Animal Health
The World Organization for Animal Health (OIE) (
http://
www.oie.int/
) is the intergovernmental organization
responsible for improving animal health worldwide,
currently with 178 Member Countries and Territories. The
OIE Terrestrial Animal Health Code (Terrestrial Code)
assures the sanitary safety of international trade in terres-
trial animals and their products through the detailing of
health measures to be used by the veterinary authorities
of importing and exporting countries to avoid the transfer of
agents pathogenic for animals or humans. Chapter 5.9 of
the Terrestrial Code is concerned with “Quarantine
measures applicable to nonhuman primates.” The OIE
Manual of Diagnostic Tests and Vaccines for Terrestrial
Animals (Terrestrial Manual) provides internationally
agreed upon diagnostic laboratory methods and require-
ments for the production and control of vaccines and other
biological products. Chapter 2.9.12 of the Terrestrial
Manual is concerned with “Zoonoses transmissible from
nonhuman primates.” The OIE recognizes air trans-
portation of nonhuman primates is of critical importance
for biomedical research. Through its official agreement
with the International Air Transport Association (IATA) it
is aware of the problems facing the commercial airline
industry and is actively raising awareness of the importance
of this international movement.
Recently the OIE have also taken an interest in the use
of animals in research. A proposal for an addition on
research animal care and use to its Terrestrial Code has
Good Laboratory Practice
The requirements of Good Laboratory Practice (GLP) in
preclinical studies across the world using animals may
include specific conditions regarding animal care and use.
For example in the US GLP Title 21 US Code 371, entitled
“Food and Drug,” and Title 42 US Code 216, 262, 263
(b-n), entitled “Public Health and Welfare,” authorize
regulations relating to food, drugs, welfare, cosmetics, and
biological products. On June 20, 1979, the US Food and
Drug Administration (FDA) finalized the GLP regulations
21 CFR, Part 58. These regulations affect both federal and
nonfederal facilities conducting nonclinical laboratory
investigations and have the objective of improving the
quality of research studies submitted to the agency.
Compliance with the AWA and the recommendations of the
Guide are required.
Good Manufacturing Practice
The requirements of Good Manufacturing Practice may
include what nonhuman primates are used, and various
animal health standards that are necessary. Both national
governments, the EU, and WHO set standards in this area.
For example in the US Standards For Viral Vaccines Title
42 US Code 262, entitled “Public Health and Welfare,” is
the law that authorizes the FDA to license and regulate the
manufacture of viral vaccines and other biological prod-
ucts. The implementing regulations for this law, 21 CFR
