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    Investigator brochure


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    1 : Investigator Brouchure (I.B.) By: Santosh Zarkariya
    2 : Investigator Brouchure The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.
    3 : Purpose of I.B. Its purpose is to provide Information to the investigators and others involved in the trial such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial. The information should be presented in a concise and simple manner
    4 : Purpose of I.B I.B. enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. For this reason, a medically qualified person should generally participate in the editing of an IB
    5 : Contents of I.B. The Investigator Brochure should include: 1) Title Page This section contains the sponsor's name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date.
    6 : Contents of I.B. 2) Confidentiality Statement The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential document 3) Summary A brief summary should be given, highlighting the significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available
    7 : Contents of I.B. 4) Description of I.P. Physical,Chemical and pharmaceutical properties of I.P. Storage and handling of I.P. Any structural similarity with the other known compound given
    8 : Contents of I.B. 5) Non Clinical Studies The results of all relevant nonclinical pharmacology, toxicology, pharmacokinetic, and investigational product metabolism studies should be provided in summary form. The information provided may include: Species tested, number of sex in each group Unit dose (e.g., milligram/kilogram (mg/kg), dose interval, route of administration and duration of dosing.
    9 : Contents of I.B.   Non clinical Studies (a) Nonclinical Pharmacology A summary of the pharmacological aspects of the investigational product studied in animals, should be included.
    10 : Contents of I.B. (b) Pharmacokinetics and Product Metabolism in Animals A summary of the pharmacokinetics(ADME) and biological transformation and disposition(getting a drug into its appropriate position in the body and in an appropriate concentration) of the investigational product in all species studied should be given.
    11 : Contents of I.B. (c) Toxicology (The study of the adverse effects of chemicals on animals) A summary of the toxicological effects found in relevant studies conducted in different animal species.
    12 : Contents of I.B. 6) Effects in Humans A thorough discussion of the known effects of the investigational product(s) in humans should be provided, including information on pharmacokinetics, metabolism, Pharmacodynamics, dose response, safety, efficacy, and other pharmacological activities.
    13 : Contents of I.B. (a) Pharmacokinetics and Product Metabolism in Humans A summary of information on the pharmacokinetics of the investigational product(s) should be presented. (b) Safety and Efficacy A summary of information should be provided about the investigational product's safety, efficacy, pharmacodynamics
    14 : Contents of I.B. (c) Marketing Experience The IB should identify countries where the investigational product has been marketed or approved.
    15 : Contents of I.B. 7)Summary of Data and Guidance for the Investigator This section should contain nonclinical and clinical data of IP.
    16 : I.B. is the handbook of the investigator carrying out safe and successful clinical trial
    17 : Thank You

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