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  • Nature of Drugs and Drug Development Ad Regulations PDF

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    Maan Masangcay
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    The document discusses the nature of drugs and drug development and regulation. It covers topics such as pharmacology versus toxicology, the nature of drugs and drug-body interactions, the process of drug development which includes discovery, development, screening, and clinical trials, and local drug regulations. The goal of the document is to provide an overview of these topics related to drugs and the processes involved in their creation and regulation.

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    The document discusses the nature of drugs and drug development and regulation. It covers topics such as pharmacology versus toxicology, the nature of drugs and drug-body interactions, the process of drug development which includes discovery, development, screening, and clinical trials, and local drug regulations. The goal of the document is to provide an overview of these topics related to drugs and the processes involved in their creation and regulation.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    96 views25 pages

    Nature of Drugs and Drug Development Ad Regulations PDF

    Uploaded by

    Maan Masangcay
    The document discusses the nature of drugs and drug development and regulation. It covers topics such as pharmacology versus toxicology, the nature of drugs and drug-body interactions, the process of drug development which includes discovery, development, screening, and clinical trials, and local drug regulations. The goal of the document is to provide an overview of these topics related to drugs and the processes involved in their creation and regulation.

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    © All Rights Reserved
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    of 25

    The Nature of Drugs

    & Drug Development


    and Regulation
    Karl C. Ablola, M.D.
    Pharmacology and Toxicology
    University of Santo Tomas
    Topics
    GENERAL PRINCIPLES

    Pharmacology versus Toxicology


    Nature of Drugs
    Drug-Body Interactions
    Drug Development and Regulation
    Clinical Trials
    Local Regulations
    CASES

    FIND THE RIGHT


    POSITION
    A 35-year old male patient a 29 year-old female patient
    asked you about his upper desires to whiten her skin.
    respiratory tract infection. He She inquired about IV
    claims that he read in facebook
    Glutathione. What
    that herbal medications are
    advantages does an IV
    safer and more effective than
    Glutathione have over that of
    conventional medications. How
    Oral Glutathione?
    will you answer this statement.
    STUDY OF SUBSTANCES
    THAT INTERACT WITH
    LIVING SYSTEMS
    THROUGH CHEMICAL
    PROCESSES.

    PHARMACOLOGY
    SCIENCE OF SUBSTANCES
    USED TO PREVENT,
    DIAGNOSE AND TREAT
    DISEASE.
    MEDICAL
    PHARMACOLOGY
    HISTORY OF PHARMACOLOGY

    1500'S 17TH CENTURY 18TH AND 19TH PRESENT


    Humorism Materia Medica CENTURY Controlled Clinical Trials
    Experimental Physiology Evidence-Based
    Excess or deficiency in Precursor of and Pharmacology Medicine
    the four humours cause Pharmacology Pharmacogenomics
    disease versus
    Alternative Herbal
    Medicine
    GENERAL PRINCIPLES

    CHEMICALS IN ALL SUPPLEMENTS


    ALL SUBSTANCES CAN
    BOTANICALS ARE NO SHOULD MEET THE SAME
    UNDER CERTAIN
    DIFFERENT FROM STANDARDS OF EFFICACY
    CIRCUMSTANCES BE
    MANUFACTURED EXCEPT AND SAFETY AS
    TOXIC
    FOR THE MUCH GREATER CONVENTIONAL DRUGS
    IMPURITIES IN THE
    BOTANICALS
    DRUG SIZE
    PHYSICAL NATURE
    MW 100 - 1000 OF DRUGS
    Lower limit = Higher Selective
    Bonding
    Upper limit = movement within the
    body

    DRUG RECEPTOR BONDS

    Covalent Bonds DRUG SHAPE


    Electrostatic Bonds
    Hydrophobic Bonds
    *Weaker bonds are more receptor
    selective
    Aspirin (Acetylsalicylic Acid)
    irreversible inhibitor of Cyclooxygenase 1
    PHARMACODYNAMICS PHARMACOKINETICS
    ACTIONS OF THE BODY ON THE
    ACTIONS OF THE DRUG ON THE
    DRUG
    BODY
    PHARMACOKINETICS

    ABSORPTION DISTRIBUTION METABOLISM ELIMINATION


    PERMEATION
    New Drugs

    Discovery Development Screening


    NO-EFFECT DOSE

    Preclinical Maximum dose at which a


    specified toxic effect is not seen.

    Safety and
    Toxicity Testing MINIMUM LETHAL DOSE
    Smallest dose that is observed to
    kill any experimental animal

    MEDIAN LETHAL DOSE 


    The dose that kills approximately
    50% of the test animals
    GENERICS ACT OF
    LOCAL DRUG
    1998 (RA 6675) REGULATIONS

    FDA ACT OF 2009


    (RA 9711) COMPREHENSIVE
    DANGEROUS DRUGS
    ACT OF 2002 (RA
    9165)

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