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    Toxi 2 PDF

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    Abhipsa Sinha
    These documents contain exam questions for a Pharmacology degree course focusing on pharmacological and toxicological screening methods. The questions cover topics such as reproductive toxicity studies, IND applications, repeated dose oral toxicity studies, good laboratory practices, renal and GI toxicity studies, dermal toxicity studies, alternative toxicity testing methods, carcinogenicity testing, point mutations, spermatogenesis, OECD and EPA toxicity guidelines, inhalation toxicity, genotoxicity, male reproductive toxicity studies, drug development safety assessment, regulatory toxicology, clinical signs toxicity, reproductive toxicology, allergenicity testing, GLP, xenobiotics, immunotoxicity, and toxicokinetics.

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    Toxi 2 PDF

    Uploaded by

    Abhipsa Sinha
    83 views4 pages
    These documents contain exam questions for a Pharmacology degree course focusing on pharmacological and toxicological screening methods. The questions cover topics such as reproductive toxicity studies, IND applications, repeated dose oral toxicity studies, good laboratory practices, renal and GI toxicity studies, dermal toxicity studies, alternative toxicity testing methods, carcinogenicity testing, point mutations, spermatogenesis, OECD and EPA toxicity guidelines, inhalation toxicity, genotoxicity, male reproductive toxicity studies, drug development safety assessment, regulatory toxicology, clinical signs toxicity, reproductive toxicology, allergenicity testing, GLP, xenobiotics, immunotoxicity, and toxicokinetics.

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    These documents contain exam questions for a Pharmacology degree course focusing on pharmacological and toxicological screening methods. The questions cover topics such as reproductive toxicity studies, IND applications, repeated dose oral toxicity studies, good laboratory practices, renal and GI toxicity studies, dermal toxicity studies, alternative toxicity testing methods, carcinogenicity testing, point mutations, spermatogenesis, OECD and EPA toxicity guidelines, inhalation toxicity, genotoxicity, male reproductive toxicity studies, drug development safety assessment, regulatory toxicology, clinical signs toxicity, reproductive toxicology, allergenicity testing, GLP, xenobiotics, immunotoxicity, and toxicokinetics.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    83 views4 pages

    Toxi 2 PDF

    Uploaded by

    Abhipsa Sinha
    These documents contain exam questions for a Pharmacology degree course focusing on pharmacological and toxicological screening methods. The questions cover topics such as reproductive toxicity studies, IND applications, repeated dose oral toxicity studies, good laboratory practices, renal and GI toxicity studies, dermal toxicity studies, alternative toxicity testing methods, carcinogenicity testing, point mutations, spermatogenesis, OECD and EPA toxicity guidelines, inhalation toxicity, genotoxicity, male reproductive toxicity studies, drug development safety assessment, regulatory toxicology, clinical signs toxicity, reproductive toxicology, allergenicity testing, GLP, xenobiotics, immunotoxicity, and toxicokinetics.

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    You are on page 1of 4

    THE TAMIL NADU DR. M.G.R.

    MEDICAL UNIVERSITY

    [LM 986] MAY 2018 Sub. Code: 2986

    M.PHARM. DEGREE EXAMINATION


    (PCI New regulations 2016)
    SEMESTER-II
    BRANCH–VI  PHARMACOLOGY  MPL
    PAPER II – PHARMACOLOGICAL AND TOXICOLOGICAL
    SCREENING METHODS  II

    Q.P. Code : 262986

    Time : Three hours Maximum : 75 Marks

    I. Elaborate on: (2 x 20 = 40)

    1. Describe in detail the reproductive toxicity studies as specified in the ICH


    guidelines.

    2. a) What is IND and what is its importance?


    b) What are the documents to be submitted to the regulatory authorities as per
    Schedule Y before carrying out the clinical trial of a new drug in India?

    II. Write notes on: (7 x 5 = 35)

    1. Core battery CNS tests.


    2. Repeated dose oral toxicity studies.
    3. Good laboratory practices.
    4. In vitro methods for assessing renal toxicity.
    5. GI toxicity studies.
    6. OECD-dermal toxicity studies.
    7. Alternative methods to animal toxicity studies.

    *********
    THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY

    [LN 986] NOVEMBER 2018 Sub. Code: 2986

    M.PHARM. DEGREE EXAMINATION


    (PCI New regulations 2016)
    SEMESTER-II
    BRANCH–VI  PHARMACOLOGY  MPL
    PAPER II – PHARMACOLOGICAL AND TOXICOLOGICAL
    SCREENING METHODS  II

    Q.P. Code : 262986

    Time : Three hours Maximum : 75 Marks

    I. Elaborate on: (2 x 20 = 40)

    1. Describe the endocrine alterations in female reproductive system, maternal and


    development toxicity.

    2. a) Explain various studies for carcinogenicity testing.


    b) Give an over view of point mutations.

    II. Write notes on: (7 x 5 = 35)

    1. Spermatogenesis.
    2. Write about OECP guidelines for toxicity studies.
    3. Adverse event reporting in clinical trials.
    4. Write on acute toxicity studies of novel drugs and its significance.
    5. Ocular toxicity testing.
    6. Discuss the steps involved in the conduct of a IND.
    7. Alternative methods to animal toxicity testing.

    *******
    THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY

    [LO 986] MAY 2019 Sub. Code: 2986

    M.PHARM. DEGREE EXAMINATION


    (PCI New regulations 2016)
    SEMESTER-II
    BRANCH–VI  PHARMACOLOGY  MPL
    PAPER II – PHARMACOLOGICAL AND TOXICOLOGICAL
    SCREENING METHODS  II

    Q.P. Code : 262986

    Time : Three hours Maximum : 75 Marks

    I. Elaborate on: (2 x 20 = 40)

    1. Describe in detail the OECD principles of Good Laboratory Practice (GLP).

    2. Describe various methods of evaluation of toxicokinetics in preclinical studies.

    II. Write notes on: (7 x 5 = 35)

    1. Concept and importance of drug development.


    2. What is IND and write its importance?
    3. Toxicity studies specified in EPA guidelines.
    4. OECD inhalational toxicity studies.
    5. Invivo carcinogenicity studies.
    6. Invivo methods of genotoxicity.
    7. Invivo methods of assessing male reproductive toxicity studies.

    *******
    THE TAMIL NADU DR. M.G.R. MEDICAL UNIVERSITY

    [LP 986] NOVEMBER 2019 Sub. Code: 2986

    M.PHARM. DEGREE EXAMINATION


    (PCI New regulations 2016)
    SEMESTER-II
    BRANCH–VI  PHARMACOLOGY  MPL
    PAPER II – PHARMACOLOGICAL AND TOXICOLOGICAL
    SCREENING METHODS  II

    Q.P. Code : 262986

    Time : Three hours Maximum : 75 Marks

    I. Elaborate on: (2 x 20 = 40)

    1. a) Explain the new drug safety assessment as per ICH guidelines.


    b) What is the regulatory toxicology?

    2. a) Describe the experimental considerations for toxicity assessment on humans.


    b) Give an account of dermal toxicity.

    II. Write notes on: (7 x 5 = 35)

    1. Write about the clinical signs toxicity.


    2. Write a note on reproductive toxicology.
    3. Allergenicity testing.
    4. Good Laboratory Practice (GLP).
    5. Xenobiotics.
    6. Immunotoxicity.
    7. Toxicokinetics.

    *******

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