Download OU M.Pharma Pharmacology 2nd Sem 2020 6122 PCI Pharmacological And Toxicological Screening Methods ? Ii Question Paper

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Code No. 6122 / PCI

FACULTY OF PHARMACY

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M. Pharmacy (Pharmacology) II - Semester (PCI) (Suppl.) Examination, January 2020

Subject: Pharmacological & Toxicological Screening Methods - I

Time: 3 Hrs Max.Marks: 75

Note: Answer any five questions. All questions carry equal marks.

1. Discuss the ICH guidelines for toxicity studies in detail.

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2. 1. Write about various studies required for IND submission.
   2. Write the role and responsibilities of:
      1. Sponsor
      2. Investigator in clinical research

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3. Write a note on:
   1. Teratogenicity studies
   2. In vivo carcinogenicity studies.
4. 1. Describe the spermatogenesis
   2. Explain the possible toxicity effects on reproductive endocrinology.

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5. 1. Explain the principles of GLP (Good Laboratory Practice) as per OECD guidelines for toxicity studies.
6. Write a note on:
   1. Chromosomal aberration test
   2. In vivo micronucleus test

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7. 1. Explain principles of toxicokinetics.
   2. Write a note on dermal toxicity testing.
8. 1. Explain the various factors influencing the toxicity evaluation studies with animal models.

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   2. Write about acute, sub-acute and chronic toxicity studies as per OECD guidelines.