Principles of Toxicology Detailed Syllabus for Pharmacology M.Pharm first year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Principles of Toxicology M.Pharm 2017-2018 (R17) first year second sem is as follows.
M.Pharm. I Year II Sem.
Course Objective: This subject imparts knowledge on the preclinical safety and toxicological evaluation of drug & new chemical entity. This knowledge will make the student competent in regulatory toxicological evaluation.
Course Outcome: Upon completion of the course, the student shall be able to,
- Explain the various types of toxicity studies.
- Appreciate the importance of ethical and regulatory requirements for toxicity studies.
- Demonstrate the practical skills required to conduct the preclinical toxicity studies.
UNIT I : Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive), Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y. OECD principles of Good laboratory practice (GLP) History, concept and its importance in drug development
UNIT II : Acute, sub-acute and chronic-oral, dermal and in halational studies as per OECD guidelines. Acute eye
irritation, skin sensitization, dermal irritation, & dermal toxicity studies. Test item characterization importance and methods in regulatory toxicology studies
UNIT III: Reproductive toxicology studies, Male reproductive toxicity studies, female reproductive studies (segment I and segment III), teratogenecity studies (segment II) Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus and Chromosomal aberrations studies) In vivo carcinogenicity studies
UNIT IV: IND enabling studies (IND studies)- Definition of IND, importance of IND, industry perspective, list of studies needed for IND submission. Safety pharmacology studies- origin, concepts and importance of safety pharmacology. Tier1- CVS, CNS and respiratory safety pharmacology, HERGassay. Tier2- GI, renal and other studies
UNIT V : Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies. Alternative methods to animal toxicity testing.
REFERENCES:
- Hand book on GLP, Quality practices for regulated non-clinical research and development (http://www.who.int/tdr/publications/documents/glphandbook.pdf).
- Schedule Y Guideline: drugs and cosmetics (second amendment) rules, 2005, ministry of health and family welfare (department of health) New Delhi
- Drugs from discovery to approval by Rick NG.
- Animal Models in Toxicology, 3rd Edition, Lower and Bryan
- OECD test guidelines.
- Principles of toxicology by Karen E. Stine, Thomas M. Brown.
- Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
(http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm 073246.pdf)
For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Pharmacology 1st Year 2nd Sem Course Structure for (R17) Batch.
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