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Investigational New Drug Application (INDA)

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Title: INDA Author: Dharmendra Chaudhari Last modified by: Hitesh Created Date: 3/28/2005 2:23:06 PM Document presentation format: On-screen Show (4:3) – PowerPoint PPT presentation

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Title: Investigational New Drug Application (INDA)


1
Investigational New Drug Application (INDA)
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LIST OF CONTENTS..
  • What is INDA ?
  • Types of INDAs
  • Objectives of INDAs
  • Format Contents of an INDA
  • IND Safety reports
  • IND Annual Reports
  • IND Review Process
  • Withdrawal of an IND
  • Inactive Status
  • References

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  • What is INDA ?

(Fig. Flow chart illustrating the various steps
in preclinical and clinical development of
pharmaceutical Products)
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  • INDA is a vehicle through which a sponsor
    advances to the next stage of drug product
    development known as clinical trials (human
    trials) .
  • It includes data and information in three broad
    areas
  • Animal Pharmacology and Toxicology Studies
  • Manufacturing Information
  • Clinical Protocols and Investigator Information
  • The regulations in 21 CFR 312 cover procedures
    and requirements for Investigational New Drug
    Applications (INDAs) .
  • These regulations define the roles and
    responsibilities of FDA reviewers, IND sponsors,
    and clinical investigators .

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  • Sponsor
  • A sponsor is an individual, company, institution,
    or organization that takes responsibility for and
    initiates a clinical study (21 CFR 312.3(b),
    312.50)
  • A sponsor is responsible for
  • Selecting qualified investigators
  • Ensuring study monitoring
  • Maintaining an effective IND, and
  • Ensuring AE risk information is provided to the
    FDA and investigators

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  • Investigator
  • An investigator is an individual under whose
    immediate direction the study drug is
    administered or dispensed. If a team is involved,
    the leader is the investigator other team
    members are sub-investigators
  • (21 CFR 312(b), 312.60) .
  • An investigator is responsible for
  • Ensuring the study is conducted according to the
    plan
  • Protecting the rights, safety and welfare of
    subjects, and
  • Control of drug under investigation

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  • Sponsor-Investigator
  • A sponsor-investigator is an individual who both
    initiates and conducts a study and under whose
    immediate direction the study drug is
    administered or dispensed. This person must
    follow the requirements pertaining to a sponsor
    and those pertaining to an investigator (21 CFR
    312(b)) .

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Types of INDs
  1. Commercial INDs
  2. Emergency use INDs
  3. Treatment INDs

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Objectives of INDA
  • To focus FDAs attention during early phase of
    clinical research on assuring the safety of human
    test subjects.
  • To provide sponsors with a greater measure of
    flexibility in conducting Phase 1 trials.
  • To facilitate consultation between FDA
    sponsors, especially after there is an indication
    that the new drug is safe and efficacious in
    humans.

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Format Contents of an INDA(21 CFR 312.23)
  • Cover Sheet (Form FDA 1571)
  • Table of Contents
  • Introductory Statement General investigational
    plan
  • Investigators Brochure
  • Protocols
  • Chemistry, Manufacturing Control Information
  • Previous Human Experience with the
    Investigational Drug
  • Additional Information

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Cover Sheet (Form FDA 1571)
  • Name of drug
  • Submission date
  • Sponsor identification
  • Phase of proposed clinical investigation
  • Sponsor commitments
  • Identification of clinical monitor and safety
    evaluator
  • Information regarding transfer of
    responsibilities to a contract research
    organization

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Table of Contents
  • Drug Name
  • IND table of contents
  • Item Title
    volume/page
  • 3 Introductory statement general
    investigational plan
  • (i) Introductory statement.
  • (ii) summary of previous human experience
    with drug.
  • (iii) If the drug has been withdrawn from
    Investigation/ Marketing
  • iv) General Investigational Plan..

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5 Investigators Brochure. 6 Protocol.. 7
Chemistry, Manufacturing Control Information
(a) Drug substance (b) Drug
Product. (c) Placebo (if applicable)
(d) Labeling. (e) Environmental
Analysis . 8 Pharmacology Toxicology
Information.
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  • Previous Human Experience with the
    Investigational Drug.
  • (i) Summary of Previous Human Experience.
  • (ii) If the drug is a combination of drug
    previously investigated/ marketed.
  • (iii) If the drug has been marketed outside
    the United States
  • 10 Additional Information (as applicable for
    radioactive drugs or drugs with dependence or
    abuse potential).

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Introductory Statement General Investigational
Plan
  • It consists of four subsections
  • 1st subsection (Introductory statement)
  • Name of drug
  • Pcological Class
  • Structural formula
  • Route of administration
  • Broad objectives
  • Planned duration of the proposed clinical
    investigation

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  • 2nd subsection
  • Brief summary of any previous human experience
    with the drug, including investigational or
    marketing experience in other countries .
  • 3rd subsection
  • It is a statement as to whether or not the drug
    has been withdrawn from investigation or
    marketing in any country for any reason of safety
    or efficacy .

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  • 4th subsection
  • Brief description of overall investigational plan
    for drug during the following year like
    Indications to be studied, kinds of clinical
    trials to be conducted in first year.

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Investigators Brochure (IB)
  • Sponsor must provide to all clinical
    investigators, not required for sponsor
    investigators (21 CFR 312.55).
  • It must include
  • Brief product description
  • Pharmacology/toxicology summaries
  • Previous human experience
  • Description of anticipated risk and any special
    monitoring needs
  • Updates as appropriate

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  • Drug Name
  • Investigator's Brochure
  • Table of contents
  • Page
  • Introduction..
  • Chemistry.
  • Physical Properties
  • How Supplied.
  • Pharmacology.
  • Specific Effect Studies
  • General Studies.

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  • Toxicology..
  • Acute Toxicity.
  • Multidose Toxicity.
  • Special Toxicity Studies
  • Reproductive Studies
  • Mutagenicity Studies.
  • Pharmacokinetics
  • Preclinical.
  • Clinical.
  • Clinical Trial.
  • Phase 1
  • Phase 2/3 .

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  • Safety/Efficacy Overview
  • Safety..
  • Efficacy..
  • Possible Risks and Side Effects
  • References.

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Protocols
  • Phase 1 protocol provides an outline of
    investigation by specifying information such as
    estimated number of test subjects,
    inclusion/exclusion criteria and dosing plan.
  • Phase 2 and Phase 3 protocols are detailed,
    describing all aspects of the studies, such that
    any deviation in a design if required, it can be
    established in the protocol from the beginning.

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All the protocols are required to contain the
following elements
  • Statement of the objectives and purpose of the
    study
  • Patient inclusion/exclusion criteria
  • Estimate of number of patients to be studied
  • Description of study design
  • Dosing information including planned maximum
    dosage and duration of individual patient
    exposure to the Drug
  • Description of the observations and measurements
    planned to fulfill the study objectives

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Chemistry, Manufacturing Control Information
  • Drug Substance
  • Physical, chemical or biological characteristics
    of the drug substance, along with the name and
    address of the manufacturer
  • Description of the general method of preparation,
    identification of the analytical methods and
    acceptable limits used to assure the identity,
    purity and strength of the drug substance
  • Stability data must be sufficient to support the
    stability of drug substance throughout the
    preclinical and proposed clinical studies

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  • Drug Product
  • Qualitative Quantitative compositions
  • Manufacturing facility, manufacturing and
    packaging procedure, identification of analytical
    methods, acceptable limits used to assure
    identity, purity, and strength of components and
    finished products
  • Stability data to support duration of proposed
    clinical studies.
  • Labeling
  • A copy of all labels and labeling to be provided
    to each clinical investigations must be
    submitted.
  • Environmental Analysis
  • Identification and quantities of any chemical
    substances emitted during the manufacture of the
    product, use of resources and energy, etc.

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  • Previous Human Experiences with the
    Investigational Drug
  • Such findings if available must be submitted
    whether drug is marketed in U.S. or other foreign
    country.
  • Additional Information
  • Any information that sponsor believes will aid in
    the evaluation of the application.
  • IND Amendments
  • Protocol Amendments
  • Information Amendments

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IND Safety Reports
  • If a sponsor notify any unexpected fatal / life
    threatening experience associated with the use of
    the drug requires to notify the FDA by telephone
    no later than 3 working days after receipt of the
    information, followed by a written report within
    10 days.

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IND Annual Reports
  • (21 CFR 312.33)
  • To be submitted within 60 days of the anniversary
    of in effect date
  • Include enrollment, demographic and conduct
    status information for each study
  • Adverse event summaries (safety reports, deaths,
    dropouts)
  • Drug action information
  • Preclinical study status information

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IND Review Process
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Withdrawal of an IND
  • It is option of a sponsor to withdraw an IND at
    any time without prejudice.
  • On withdrawn, sponsor must notify the FDA.

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Inactive Status
  • On sponsors request FDA may place an IND on
    inactive status if no subjects have entered
    clinical studies for at least two years or if the
    IND has been on clinical hold for at least one
    year.
  • After remaining on inactive status for five
    years, the FDA may terminate an IND.

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List of References
  • 1.www.fda.gov/cder/about/history/time1.htm
  • 2.Remington the science and practice of pharmacy,
    20th edition, Lippincott,Williams Wilkins, page
    no 930-943
  • 3. New Drug Approval Process second Edition,
    Revised and Expanded, edited by Richard A.
    Guarino page no 39-64, 243-263
  • 4.www.fda.gov/cder/handbook/indbox.htm
  • 5.www.fda.gov/cder/handbook/ndabox.htm
  • 6.www.fda.gov

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Thanks to All
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