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    Misha Regulatory Affairs

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    GULSHAN MADHUR
    The document discusses non-clinical drug development. It begins by explaining that the goal of non-clinical development is to identify promising candidate therapies, assess safety, and build scientific foundations before clinical trials. Studies include in vitro, in vivo, and in silico experiments to determine safety, efficacy, dosing, and manufacturing feasibility. Guidelines from organizations like the EMA must be followed. The extent of non-clinical testing depends on factors like the type of product and intended patient population. Non-clinical work provides information needed for clinical trial approval and marketing authorization applications.

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    Misha Regulatory Affairs

    Uploaded by

    GULSHAN MADHUR
    56 views26 pages
    The document discusses non-clinical drug development. It begins by explaining that the goal of non-clinical development is to identify promising candidate therapies, assess safety, and build scientific foundations before clinical trials. Studies include in vitro, in vivo, and in silico experiments to determine safety, efficacy, dosing, and manufacturing feasibility. Guidelines from organizations like the EMA must be followed. The extent of non-clinical testing depends on factors like the type of product and intended patient population. Non-clinical work provides information needed for clinical trial approval and marketing authorization applications.

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    MISHA REGULATORY AFFAIRS. ppt

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    The document discusses non-clinical drug development. It begins by explaining that the goal of non-clinical development is to identify promising candidate therapies, assess safety, and build scientific foundations before clinical trials. Studies include in vitro, in vivo, and in silico experiments to determine safety, efficacy, dosing, and manufacturing feasibility. Guidelines from organizations like the EMA must be followed. The extent of non-clinical testing depends on factors like the type of product and intended patient population. Non-clinical work provides information needed for clinical trial approval and marketing authorization applications.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    56 views26 pages

    Misha Regulatory Affairs

    Uploaded by

    GULSHAN MADHUR
    The document discusses non-clinical drug development. It begins by explaining that the goal of non-clinical development is to identify promising candidate therapies, assess safety, and build scientific foundations before clinical trials. Studies include in vitro, in vivo, and in silico experiments to determine safety, efficacy, dosing, and manufacturing feasibility. Guidelines from organizations like the EMA must be followed. The extent of non-clinical testing depends on factors like the type of product and intended patient population. Non-clinical work provides information needed for clinical trial approval and marketing authorization applications.

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    © All Rights Reserved
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    of 26

    NON CLINICAL DRUG DEVELOPMENT

    IN THE GUIDENCE OF; PRESENTED BY;


    Mrs. S.G. PANPALIA MA’AM MISHA SHRIVASTAVA
    ASSOCIATE PROFESSOR M.PHARM ( I-SEMESTER)
    DEPT. OF PHARMACEUTICAL SCIENCE DEPT. OF PHARMACEUTICS
    & TECHNOLOGY, BIT MESRA BIT MESRA, RANCHI
    RANCHI, JHARKHAND
    INTRODUCTION

    The non-clinical (or pre-clinical) development phase primarily
    aims to identify which candidate therapy has the greatest
    probability of success, assess its safety, and build solid scientific
    foundations before transition to the clinical development phase.
    The main goals of preclinical studies are to determine a starting,
    safe dose for first in human study and assess potential toxicity of
    the product, which typically include new medical
    devices, prescription drugs, and diagnostics.
    Also , during the non clinical development phase the candidate
    compound should meet non-medical objectives, including
    defining the intellectual property rights and making enough
    medicinal products available for clinical trials.
    THE STUDIES OF NON CLINICAL
    DEVELOPMENT ARE PERFORMED

    1. IN-VITRO- Performing a procedure in a controlled environment outside of a living


    organism; for example, using hepatocyte culture for metabolism studies.
    2. IN-VIVO- Experimentation using a whole living organism as opposed to tissues or
    cells; for example, in animals or plants.
    3. IN-SILICO- Performed on computer; for example, predicting the toxicology profile
    of a product using its chemical structure with data based approaches.
    OBJECTIVES

    Once a candidate compound is identified, the non-clinical development should start


    answering the following questions, and answers will come from specific studies.
    1. Does it work?
    2. How will it be delivered and how will the body react?
    3. Is it safe?
    4. Is the manufacture viable and controllable?
    Non-clinical development activities can continue throughout the life cycle of the product,
    although the earlier these questions are answered, the easier it is to identify the profile of
    the patient who will benefit most.
    WHY ARE NON-CLINICAL
    STUDIES NEEDED?
     Information obtaineds in non-clinical studies is needed in specific situations for decisions:-
    i. On clinical trials.
    ii. On marketing authorization applications.
    iii. On post marketing or monitoring studies.
     Non- clinical information is also used:-
    i. To determine first in human doses of the compound.
    ii. In clinical studies specific on heart function.
    iii. In safety monitoring in different systems.
    EXTENT OF NON-CLINICAL
    TESTING
    The extent & scope of the non-clinical development programme before, during and after
    clinical trials is determined according to the following factors:
    i. Type of medicinal product
    ii. Type & severity of the disease
    iii. Population intended to treat
    iv. Clinical trial phase ( I, II, III and post marketing phase IV)
    v. Anticipated dose & duration of the treatment duration in humans.
    NON-CLINICAL REGULATORY
    GUIDELINES
    There are many players involved in the development of medicines, and each organization
    or institute follows their own set of rules. For instance, companies have their standard
    operating procedures (SOP).
    In addition to good clinical practice provision, guidelines can be consulted at the
    European Medicines Agency (EMA) websites.
     They are either general or more specific addressing scientific & technical aspects.
     They must be strictly followed for any new marketing authorization application; any
    deviation must be justified.
    NON-CLINICAL DEVELOPMENT IN CTD MODULES
    INVESTIGATIONAL NEW DRUG
    (IND)
    IND is defined under 21 CFR 312.3(b) as ‘ a new drug or biological drug that is used in clinical investigation.’
    The term also includes a biological product used in-vitro for diagnostic purpose.
    After pre-clinical investigations when the new molecule has been screened for pharmacological activity &
    acute toxicity potential in animals the sponsor requires permission from FDA for clinical trials in humans.
    The sponsor submits the application for conduct of human clinical trials called investigational new drug(IND)
    application to FDA or DCGI.
    Once IND application is submitted, the sponsor must wait for 30 days before initiating any clinical trials.
    Clinical trials in human can begin only after IND is reviewed by the FDA and a local institutional review board
    (IRB).
    IRBs approve clinical trials protocol, informed consent of all participants & appropriate steps to prevent
    subjects from harm.
    TYPES OF INDs

    1. COMMERCIAL INDs
    • These are applications that are submitted primarily by the companies to obtain marketing approval for a new product.
    2. NON-COMMERCIAL INDs
    • These INDs are filed for noncommercial research.
    THESE ARE:
     INVESTIGATOR’S IND- It is submitted by a physician who both initiates & conducts an investigation and who also
    administered & dispenses the IP.
     EMERGENCY USE IND- This IND allows FDA to allow the use of an experimental drug in an emergency situation
    that does not allow submission of an IND in accordance with 21 CFR Sec321.23 or Sec312.34.
     TREATMENT IND- Also called expanded access IND, it may be submitted for experimental drugs showing promise
    in clinical testing of serious and immediately life threatening conditions while in final clinical work is conducted and
    the FDA review takes place.
    CRITERIA FOR IND APPLICATION

    • A new indication
    • Change in the approved route
    of administration or dosage
    level.
    • Change in the approved
    patient population.
    • Significant change in the
    promotion of an approved
    drug.
    IND PROCESS IN INDIA
    NEW DRUG APPLICATION (NDA)

     The NDA is the vehicle through which the drug sponsors formally propose FDA or DCGI to approve a
    new investigational drug for sale & marketing after phase IIIA pivot trials.
     The official definition of new drug is in Sec 201(p) of Federal drug, food & cosmetics act as;
    Any new drug, the composition of which is such that it is not recognized among experts qualified by
    scientific training as safe and effective foe use under prescribed, recommended or suggested conditions.
     Any drug the composition of which is such that it as a result of investigations to determine safety &
    efficacy for use has become recognized, but which has not, otherwise in such investigations been used
    to a material extent.
     The following letter codes describes the review priority of the drug;-
    • S- STANDARD REVIEW: for drugs similar to currently available drugs.
    • P- PRIORITY REVIEW: for drugs that represent significant advances over existing treatments.
    CLASSIFICATION OF DRUGS IN
    NDA
     CENTER OF DRUG EVALUATION AND RESEARCH (CDER) classifies new drug applications
    according to the type of drug being submitted & its intended use:-
    a) New molecular entity
    b) New salt of previously approved drug
    c) New formulation of previously approved drug
    d) New combination of two or more drugs
    e) Already marketed drug product- duplication (i.e., new manufacturer)
    f) New indication for already marketed drug
    g) Already marketed drug product
    PROCESS OF NDA
    ABBREVIATED NEW DRUG
    APPLICATION (ANDA)
     Generic drug applications are referred to abbreviated new drug applications.
     Pharmaceutical companies must admit ANDAs & receive FDAs approval before marketing new generic drugs according to
    21CFR 314.105(d).
     Once ANDA is approved, an applicant can manufacture & market generic drug to provide safe, effective and low cost
    alternative of innovator drug product to the public.
     Generic drugs are termed ‘abbreviated’ as they are not required to include preclinical and clinical data to establish safety and
    efficacy. They must scientifically demonstrate bioequivalence to innovator (brand name) drug.
     A generic drug is comparable to innovator drug I dosage form, strength, route of administration, quality, performance and
    intended use.
     One of the ways to demonstrate bioequivalence is to measure the time taken by generic drug to reach blood stream in 24-36
    healthy volunteers. The time and amount of active ingredients in the blood stream should be comparable to those of
    innovators drugs.
     Use of bioequivalence as base for approving generic drug products was established in 1984, also known as WAXMAN-
    HATCH ACT. It is because of this act that generic drugs are cheaper without conducting costly and duplicative clinical trials.
    PROCESS OF ANDA
    NDA & ANDA
    INVESTIGATOR’S BROCHURE

     The IB is a compilation of the clinical & non clinical data on the investigational products that are relevant
    to study of the products in human subjects.
    PURPOSE:
    • Its purpose is to provide information to the investigators and others involved in the trials such as the dose,
    dose interval/frequency, method of administration and safety monitoring procedure.
    • The IB also provides insight to support the clinical management of the study subject during the course of
    the clinical trials.
    • The information should be presented in a concise and simple manner.
    • IB enables a clinician or potential investigator to understand it and make his/her own unbiased risk
    assessment of the appropriateness to the proposed trial. For this reason, a medically qualified person
    should generally participate in the editing of an IB.
    GENERAL CONSIDERATIONS

     TITLE PAGE
    1. Sponsor name
    2. The identity of each investigational product
    3. The release date
    4. Confidential statement
    CONFIDENTIALITY STATEMENT

     The sponsor may wish to include a statement instructing the investigator to treat the IB as a confidential document
    for the sole information and use of the investigator’s team and the IRB/IEC.
     The investigator brochure should include:
    1. Table of contents
    2. Summary
    3. Introduction
    4. Description of IB
    5. Non clinical studies
    6. Effects in human
    7. Summary of data & guidance for the investigator.
    THANK YOU

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