Investigated New Drug Application (IND)

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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
Presented by
RAVI SHANKAR .D. (20L81SO403)
I-M Pharmacy (Quality Assurance)
Under the guidance of
Mrs.Y.SRAVANI M.pharm (P.hD)
Assistant professor of Industrial Pharmacy
INVESTIGATIONAL NEW DRUG
APLICATION

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Agenda -
Introduction
Note
Types & Classification
 Review team
Requirements for protocols
What does IND includes
INDA review process

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K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Introduction :
• An IND is a submission to the food and drug administration (FDA) requesting
permission to initiate a clinical study of a new drug product.
• The Federal Food , Drug and Cosmetic act requires that drugs have an
approved marketing application before they can be shipped in interstate
commerce.
• The IND application allows a company to initiate and conduct clinical studies
for their new drug products.
• The IND application provides the FDA with the data necessary to decide
whether the new drug and the proposed clinical trial pose a reasonable risk to
the human subjects participating in the study.

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Note:
 Sponsor must submit an IND application to FDA prior to start the clinical research.
With in the application , developers must include
- animal study data & toxicity data
- manufacturing info
- clinical protocols for study to be conducted
- data from any prior human research
- info regarding the investigator

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TYPES :
 Investigator IND
 Emergency use IND
 Treatment IND
Classification of IND :
 Commercial
 Research ( non-commercial)
IND application must contain information in 3 broad areas
- Animal pharmacology & Toxicology studies
- Manufacturing information
- Clinical protocols & Investigator information

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FDA IND review team :
Involves a group of specialists in different scientific fields
 Project manager
 Medical officer
 Statistician
 Pharmacologist
 Pharmakineticist
 Chemist
 Microbiologist

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Pre consultation program :
 Propose - to introduce the sponsor and the drug to the FDA
 It will help a sponsor to design additional non clinical studies
 Time of meeting – within 60 days of FDA’s receipt of written request for the
meeting
 A brief document is required at least 4 weeks prior to the meeting

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Requirements for Protocols:
• The regulation requires submission of a copy of the protocol for the conduct
of each proposed clinical trial.
• The regulations state that phase 1 protocols should be directed primarily at
providing an outline of the investigation:
-- An estimate of the number of subjects to be included;
-- A description of safety exclusions;
-- A description of the dosing plan, including duration, dose, or method
to be used in determining dose.

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Requirements for CMC Information
• Chemistry, manufacturing and control information is required for
IND submission.
• Sufficient information should be submitted to assure the proper
identification, quality, purity, and strength of the investigational
drug
• The amount of information needed to make that assurance will vary
with the phase of the investigation, the proposed duration of the
investigation, the dosage form
• The identification of a safety concern or insufficient data to make an
evaluation of safety is the only basis for a clinical hold based on the
CMC section.

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Reasons are -
(a) a product made with impure components,
(b) a product possessing chemical structures of highly toxicity,
(c) a product that cannot remain chemically stable throughout the testing
program proposed,
(d) a product with an impurity profile indicative of a potential health hazard
• Sponsors should be able to relate the drug product being proposed for use in
a clinical trial to the drug product used in the animal toxicology trials that
support the safety of the proposed human trial.
• Sponsors should describe any chemistry and manufacturing differences
between the drug product proposed for clinical use and the drug product
used in the animal toxicology studies

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Information on the drug product should be submitted in a summary report
containing the following items
1. A list of all components
2. Quantitative composition
3. The name and address of the manufacturer
4. Method of manufacturing and packaging
5. Acceptable limits and analytical methods
6. Stability testing
7. Labeling
8. Environmental assessment

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Pharmacology and Toxicology Information
Pharmacology & Toxicology info:
Pharmacology -
• This section of IND should contain,
(a) a description of the pharmacologic effects and mechanism of action of the
drug in animals
(b) information on the absorption, distribution, metabolism, and excretion of
the drug.
Toxicology - integrated summary
• The IND regulations require an integrated summary of the toxicological
effects of the drug in animals and in vitro.

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The integrated summary of the toxicological findings of the completed
animal studies to support the safety of the proposed phase 1 human
investigation should ordinarily contain the following information
1. A brief description of the design of the trials, dates of performance
2. A systematic presentation of the animal toxicology and toxico kinetic trials
3. Identification and qualifications of the individual who evaluated the
animal safety data and concluded that it is reasonably safe to begin the
proposed human trial
4. A statement of where the animal trials were conducted
5. The trial should be comply with GLP.
Toxicology- full tabulation: The sponsor should submit the data about
each animal investigation, laboratory end points.

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IND includes :
1.Name of the sponsor
2.Date of submission
3. Address
4. Telephone number
5. Name(s) of Drug
6. IND Number :
If an emergency IND number was previously assigned by FDA, or the Form
FDA 1571 is being included with an amendment to the original IND, then that
IND number should be entered here; otherwise, the space should be left blank.

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7. Indication
8. Phase of clinical investigation to be conducted
9. List no. of all investigational new drug application
10. Serial no.
11. Contents of application
12. Name and title of the person responsible for monitoring the conduct and
progress of clinical investigation.
13. Is any part of the clinical study to be conducted by CRO
14. Name and title of the person responsible for review and
evaluation of information relevant to the safety of drug
15. Name of sponsor ’s authorised representative
16. Signature
17. Address

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INTRODUCTORY STATEMENT:
• Description of the investigational drug
• All active ingredients
• Drug’s pharmacological classification
• Structural formula
• Route of administration
• Summary of previous human experience
• Formulation of dosage forms
• Objective and planned duration of proposed clinical investigation.

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INVESTIGATIONAL PLAN:
• Description of clinical studies planned for the experimental drug
• Purpose of the study
• Indication to be studied
• Types of trials to be initiated
• Number of study subjects
• Risks involved

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INVESTIGATORS BROCHURE:
• Structural formula of drug.
• Summary of pharmacological , toxicological, pharmacokinetic effects in
animals.
• Safety and efficacy
• Purpose of study
• Dose / dose frequency
• Monitoring procedures

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CLINICAL PROTOCOL:
• a clinical protocol describes how a particular clinical trial
is to be conducted
• It describes
• the objectives of study
• the trial design
• how subjects are selected
• how the trial is to be carried out

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It should contain the following elements:
• A statement of the objective and purpose of study.
• Name , address and qualification of each investigator
participating in the study.
• Name and address of each clinical site.
• Study subject inclusion and exclusion criteria.
• Estimate of the number of subjects to be enrolled in the
study.

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Chemistry, Manufacturing and Control Data
• Determines the adequacy of methods used to manufacture and assay
investigational compound
• Safety concerns
• Describe drug substances
• Method of preparation
• Reagent and solvents
• Acceptable limits and analytical methods to ensure quality and purity of
drug.
Pharmacological and Toxicology data :
• Pharmacology and drug disposition
• Integrated toxicology summary
Previous human exposure :
• Marketed (foreign) or previously tested in humans.

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IND Submissions Assessments:
• The FDA’s review of phase 1 submissions focuses on assessing the safety of
those investigations.
• The central focus of the initial IND submission will be on the general
investigational plan and the protocols for specific human trials.
• An IND goes into effect 30 days after the FDA receives the IND, unless the
FDA notifies the sponsor that the investigations described in the IND are
subject to a clinical hold.
Form FDA 1571 -
• INDs and each amendment to an IND are to be submitted in triplicate and must
include a completed copy of the two-page Form FDA 1571.

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IND ANNUAL REPORTS:
• Sponsors should submit an annual report that provides the FDA with a brief
update on the progress of all investigations included in the IND.
• It should contain the following:
• Individual study information.
• Summary of the study.
• Listing of any significant foreign marketing developments
• with the drug e.g. approval in another country.

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Investigated New Drug Application (IND)

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