UNIQUE SERIES AKTU Syllabus
BP610P SEC3

Principles of Preclinical Studies (Practical)

L-T-P0-0-2 Session2026-27 TypeLab / Practical
Appears in 1 semester

B.Pharm · Sem 6 (SEC – Elective 4)

Download PDF

List of Experiments / Activities

  1. Principles of Preclinical Studies (Practical) Elective Credit Hours Per Week (L-T-P) Max. Hours L T P
  2. 1-- --
  3. 30Maximum Marks SE ESE
  4. (Perform any 12 Experiments)
  5. 1Handling, restraining, and sex differentiation of laboratory animals (demo/video)
  6. 2Calculation of dose for animals based on body surface area
  7. 3Routes of administration: oral, intraperitoneal, subcutaneous (simulation)
  8. 4Observation of behavioral effects using actophotometer/rotarod (if available)
  9. 5Determination of acute toxicity (LD50 concept) case-based calculation
  10. 6Planning a 28-day sub-acute toxicity study protocol
  11. 7Pharmacokinetic study: Cmax, Tmax, AUC calculation (sample dataset)
  12. 8Observation of histopathological slides from toxicity studies
  13. 9Demonstration of sampling methods blood, urine (case or video)
  14. 10Writing an animal study protocol using CPCSEA format
  15. 11Identification of organs for toxicity evaluation liver, kidney, brain
  16. 12Visit to CPCSEA-approved animal house/laboratory
  17. 13Observation of animal behavior grooming, nesting (case-based)
  18. 14Simulated ethics committee approval process (IAEC)
  19. 15Group activity: Design of a preclinical study for a hypothetical drug
Course Objectives6 points
  • The objectives of this course are to:
  • Introduce the role and importance of preclinical studies in the drug discovery and development process.
  • Familiarize students with laboratory animal handling, ethical considerations, and experimental protocols used in preclinical research.
  • Explain the principles of pharmacokinetics and toxicology as applied to animal models.
  • Describe the regulatory guidelines and standards governing preclinical research and animal experimentation.
  • Develop skills in analyzing and interpreting preclinical data to support decision-making for clinical trials.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Explain the role and significance of preclinical studies in drug discovery and development.
  2. CO2Demonstrate appropriate laboratory animal handling practices in accordance with ethical and regulatory guidelines.
  3. CO3Analyze pharmacokinetic parameters obtained from preclinical animal studies.
  4. CO4Design and interpret basic toxicological studies to evaluate drug safety.
  5. CO5Apply preclinical data in assessing drug candidates for progression to clinical trials.
Recommended References (Preferably latest edition):5 books
  1. Preclinical and Clinical Research A Handbook S. K. Gupta, Jaypee Brothers Medical Publishers
  2. Drug Discovery and Clinical Research B. T. James & M. M. Gupta, CBS Publishers & Distributors
  3. Textbook of Preclinical Toxicology R. K. Goyal, B. S. Shah Prakashan
  4. Fundamentals of Experimental Pharmacology M. N. Ghosh, Hilton & Company
  5. Textbook of Pharmacology S. D. Seth, Elsevier India SEMESTER VI Course Title Course Type

Previous Year Papers

Loading…

🙏 Aapke juniors aur doston ko aapki zarurat hai!

Aapke paas is subject ka koi purana paper hai? Upload kijiye. Aapka ek paper kisi junior ka exam aasaan bana sakta hai.

Upload previous year paper

Official AKTU syllabus

This subject is on page 252, 253, 254 of the original AKTU PDF.

Official AKTU syllabus PDF ↗