Lab animals CPCSEA guidlines M Pharm first Sem.pptx

Laboratory Animals
Transgenic Animals
CPCSEA Guidelines
Pharmacological and Toxicological Screenings Methods

1. Laboratory Animals, Transgenic Animals, Anesthesia & Euthanasia, CPCSEA Guidelines Presented by:- Mr. Sunil Balasaheb Sitaphale M. Pharm (Pharmacology) 1 st Year Roll no. - 15 Institute of Pharmaceutical Education and Research Borgaon ( Meghe ), Wardha .

2. CONTENT Introduction Laboratory Animals Transgenic Animals Anaesthesia & Euthanasia CPCSEA Guidelines References

3. Laboratory Animals Laboratory animals are used for different studies It may include bioassay, preclinical studies etc. Healthy and well being of lab. animal entirely depend almost entirely on a. The care b. Humanity c. Watchfulness of the staff of the animal house.

4. Classification of Laboratory Animals

5. MOUSE ( Mus musculus ) Smallest laboratory animal Easy to keep, handle and require small place for housing, uniformly breed Common strain Swiss albino mice Sensitive to small doses of drugs Biological data - Typical adult weight 20-40 g - Average life span 1.5-2.5 yrs. - Gestation period 19-21 days - Estrous cycle 4-5 days Physiological data - Heart rate – 330-780 beats /min - Resp rate – 84-230/min - Tidal volume – 0.1-0.23 ml - Daily food intake – 4-5 g • Blood collection requiring anesthesia - Tail vein - Tail snip - Orbital sinus - Jugular vein • Blood collection not requiring anesthesia - Saphenous vein - Dorsal pedal vein • Experimental uses - Toxicological studies - Teratogenicity studies • Common diseases - Salmonellosis - Ectromelia (mouse pox)

6. The Rat ( rattus norvegicus ) • Albino rat –commonest • Two strains – 1) Wistar rats Resistant to infections Low incidence of tumors Wide head Long ears 2) Sprague –Dawley Rapidly growing Longer and narrower head ↓ respiratory infections Biological data • Typical adult weight - 250 g • Average life span - 2-3yrs. • Gestation period - 21-23 days • Estrous cycle - 4-5 days Physiological data • Heart rate – 300-500 beats/min • Resp rate – 65-180/min • Tidal volume – 1.5 ml • Daily food intake – 10-20 g Special features • Do not vomit (due to strong sphincter between stomach and esophagus and lack vomiting centre ) • Do not have tonsil and gallbladder • Tail help in thermoregulation Experimental uses • Study of analgesics and anticonvulsants. • Hepatotoxicity studies • Study on mast cells

7. Rabbits ( Oryctolagus cuniculus ) • Docile animal • New Zealand white strains • Large, broad, and muscular body. Biological data • Typical adult weight 1.5-5 kg • Average life span 4-6 yrs. • Gestation period 31 days Physiological data • Daily food intake – 150-300g • Heart rate –130-300 beats/min • RR – 38-60 /min • Tidal volume – 19-24 ml • Blood volume – 4-8 (% B W) Experimental uses • Pyrogen testing • Bioassay of anti-diabetic, • Drugs used in glaucoma • Pharmacokinetic studies • animal of choice for cardiac studies • Teratogenicity studies Common diseases (Rabbit) Respiratory infections (Snuffles) Intestinal infections (mucoid enteritis, Diarrhoea ) Cage Made of galvanized iron.

8. Guinea Pigs ( Cavia porcellus ) • Docile animals • Susceptible to TB and anaphylaxis • Highly sensitive to histamine, penicillin Biological data • Typical adult weight 800 g • Average life span 3-5 yrs. • Gestation period 68 days Physiological data • Daily food intake – 40-50g • Heart rate - 260-400 beats/min • RR -70-104 /min • Blood volume – 6-12 (% B W ) Experimental uses • Study of histamine and antihistamines • Evaluation of local anesthetics • Hearing experiments study • Isolated tissues especially ileum, heart • Study on TB Common diseases (Guinea pig) Pseudo tuberculosis (acute or chronic) Respiratory tract infections Intestinal infections Viral disease

9. TRANSGENIC ANIMAL A transgenic animal is one that carries a foreign gene that has been deliberately inserted into its genome. Transgenesis is the process by which mixing up of genes takes place. Foreign genes are inserted into the germ line of the animal, so it can be transmitted to the progeny. Introduction :

10. IMPORTANCE OF TRANSGENIC ANIMALS ▸ Medical importance Xenotransplantation ▸ Agricultural importance Disease resistant animals For improving quality and quantity of milk, meat, eggs and wool production ▸ Industrial importance Toxicity sensitive transgenic animals to test chemicals.

11. Anaesthesia and Euthanasia Anaesthesia :- The word anaesthesia has been derived from Greek word that means “without perception of insensibility”. Anesthesia is the act of providing sensation-free relief from pain or pain-producing procedures. Anesthesia must be performed by a person with knowledge of and familiarity with the drugs to be used in the animal species under consideration. Euthanasia :- The term euthanasia is derived from the Greek terms ‘ eu ’ meaning good and ‘ Thanatos’ meaning death. A “good death” would be one that occurs with minimal pain and distress. In the context Euthanasia is the act of inducing humane death in an animal. “Sacrificing the experimental animal after use by gentle procedure causing minimum of physical and mental suffering is called euthanasia (Painless killing).

12. Commonly Used Laboratory Anesthetics There are numerous anesthetics available for use in rodents. Some of the more popular agents include: Chloralose Urethane Barbiturates Paraldehyde Magnesium Sulphate Ketamine Tribromo -ethanol

13. Methods of Euthanasia Chemical methods • Inhalant agents Ether, Halothane, Chloroform, Nitrogen, Nitrous oxide. • Injectable agents Barbiturates, Ethanol, ketamine. Physical methods Gunshot Cervical dislocation Microwave irradiation Thoracic (cardiopulmonary, cardiac) compression Kill traps Maceration

14. CPCSEA Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) Statutory body formed by the Act of the Indian Parliament under the Prevention of Cruelty to Animals Act, 1960 Formed in 1964 Revived in 1998, under the committed chairpersonship of Meneka Gandhi Head quarters at Chennai Includes various guidelines and sub committees "investigators have a moral responsibility to take care of laboratory animals after use"

15. This committee is composed of ✓ Members of the scientific community ✓ Regulatory authorities ✓ Animal activists. ✓ The committee has 10 experts and 3 official members

16. Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions(IAEC) CPCSEA Nominee -important link between CPCSEA and IAEC IAEC scrutinize all project proposals for experimentation on animals. For small animals- give the final approval For large animals- make its recommendation to SCLA (Sub-Committee on Large Animals) Role of CPCSEA & IAEC

17. A Biological Scientist. Two Scientists from different bio disciplines. A Veterinarian involved in care of Animals. Scientist In-Charge of Animal House Facility. The Chairman (preferably Head of the Institution / Department) and Member Secretary need to be nominated from the above five members. Other members: Main Nominee, Link Nominee, Scientist from outside and Socially Aware Nominee nominated by CPCSEA. The validity of IAEC is for 3 years. IAEC Composition

18. CPCSEA Goals: To promote the humane care of animals used in research. To provide specifications that will enhance animals well being and quality of research. Objective:- Effective functioning of Institutional animal ethical committee

19. Main Activities Registration of establishments ✓ for experiments on animals ✓ for Breeding of animals Approval of Animal House Facilities Permission of Committee for Conducting Experiments

20. CPCSEA Guidelines Veterinary care: ✓ Provided by a veterinarian ✓ Daily observation of animals adopted ✓ Quarantine, Stabilization and Separation: ✓ Quarantine period for small lab animals: one wk to one mth - Large lab animals: up to 6 weeks ✓ Physiologic, psychological and nutritional stabilization required ✓ Physical separation of animals by species to prevent anxiety and behavioral changes

21. Experimental Area Experiments should be carried out in a separate area away from the place where they are housed. Separate functional areas for ✓ surgical support ✓ treatment of animals ✓ post operative and intensive care

22. Physical facilities Building materials Durable, moisture-proof, fire resistant and pest resistant Corridor(s) Wide enough to facilitate the movement of personnel and equipment Animal room doors Should fit properly, should not be rust Exterior windows Windows are not recommended Floors Smooth, moisture proof. Drains Proper drainage, Floors should be sloped Storage areas Designed for feed, bedding, cages and materials not in use

23. Environment Temperature Between 18-29° C Humidity control Range of 30-70% Ventilation Designed with 12-15 air cycles per hour. Power and lighting System should be safe Fluorescent lights are efficient Emergency backup needed Noise control Noise free environment Concrete walls are more effective

24. Animal husbandry CAGING OR HOUSING SYSTEM The housing system should provide Adequate space, freedom of movement, normal postural adjustments Comfortable Environment Easy access to food and water Adequate ventilation

25. Food and water Food should be palatable, non-contaminated, and nutritionally adequate Feed should contain Feed should not contain moisture insecticides, hormones, antibiotics, fumigants or potential toxicants. crude fibre , crude protein and crude fat essential bits, minerals, carbohydrates heavy metals Should have continuous access to fresh, potable uncontaminated drinking water

26. Bedding Should be absorbent, free from toxic chemicals Should be removed and replaced periodically with fresh materials Ideal to change the bedding twice a week

27. Sanitation and cleanliness Animal rooms, corridors, storage spaces, and other areas should be cleaned with appropriate detergents and disinfectants Wastes should be removed regularly and frequently (waste disposal - incineration) Cages should be sanitized before animals are placed in them

28. Reference Dr . B. R Gandhare sir Vogal handbook Slideshare Wikipedia

29. Thank YOU!