pre-clinical testing Flashcards
Involves experiments conducted on living organisms, typically animals, to observe the effects of a drug in a whole-body system.
In Vivo Testing
Involves experiments conducted on living organisms, typically animals, to observe the effects of a drug in a whole-body system.
In Vivo Testing
Involves experiments performed on isolated cells, tissues, or organs outside of a living organism, providing a simplified model for studying drug effects.
In Vitro Testing
Regulatory Requirements for in vivo Studies
• Global Regulatory Bodies
• Ethical Considerations
• Standardized Protocols
The primary agency responsible for regulating animal use in drug
development in the Philippines
Bureau of Animal Industry (BAI), under the Department of Agriculture (DA)
The BAI oversees and implements the _____, which provides the legal framework for the humane treatment of animals used in research and development.
Animal Welfare Act of 1998 (Republic Act No. 8485)
Other agencies that may be involved
in regulating animal use in drug development in the Philippines
Department of Health (DOH)
Philippine Council for Health Research and Development (PCHRD)
Institutional Animal Care and Use Committees (IACUCs)
They may be involved in setting standards for the use of animals in
biomedical research.
Department of Health
They may provide guidelines and ethical review for research involving animals.
Philippine Council for Health Research and Development (PCHRD)
They are established within research
institutions to review and approve animal use protocols.
Institutional Animal Care and Use Committees (IACUCs)
They play a crucial role in the development and testing of new
drugs.
Animal models
The different rodent models
Mice
Rats
Guinea Pigs
Small size, short lifespan, easy to
breed and handle.
Mice
Larger size, longer lifespan, more
robust physiology.
Rats
Similar to humans in terms of vitamin C requirements.
Guinea Pigs
Non-Rodent Models
Primates
Pigs
Dogs
Rabbits
Closest to humans in terms of physiology and genetics, valuable for studying diseases like HIV and Alzheimer’s
Primates
Used for studying organ transplantation and cardiovascular research, similar size and anatomy to humans.
Pigs
Large animal models for studying cancer, diabetes, and cardiovascular diseases, long lifespan allows for chronic
studies.
Dogs
Used for studying reproductive and developmental toxicology, convenient size and relatively low cost.
Rabbits
They are widely used in drug research due to their physiological similarities
to humans.
Rats
Understanding different rat strains is crucial for selecting the most
appropriate model for specific research questions.
They are are an albino strain characterized by their white fur and pink eyes.
Wistar rats
They are known for their rapid growth and adaptability, making them suitable for various research purposes.
Wistar Rats