about ind and nda approval process according to USFDA. general guidelines according to USFDA.

1. UNIVERSITY INSTITUTE OF PHARMA SCIENCES
Master of Pharmacy
Regulator affairs
Topic-Non clinical studies
TARIQ HUSAIN
23MPH10001

2. INVESTIGATIONAL NEW DRUG
.
.

3. Introduction
• The non clinical studies also known as pre-clinical studies
majorly aims to determine the safety, efficacy and with most
therapeutic effect before transformation it into clinical trials.
• In this phase studies will perform only in animals, vivo, vitro
and in silica.

4. Studies of non-clinical trials
• Animals like rodent, guniea pig, mouse and etc. are used to do
research.
• In silica;-these are performed on computer system.
• In vitro;-studies perform in lab outside of a living organism
• In vivo;-studies perform in using a whole living organism i.e.
mice, rats, rabbits, guinea pigs, hamsters

5. Objectives of non-clinical studies
• With the help of non clinical studies one can easily answer
following question.
• About the safety, quality and efficacy of the drug .
• About the therapeutic effect.
• If any adverse drug reaction.
• About Pharmacodynamic and pharmacokinetic study

6. IND [investigational new drug]
• These drugs define under 21CFR312.3 as a new drug that is
used in clinical investigation.
• Biological product are also used
• After successfully completing non-clinical trials.
• Then the sponsor require permission from FDA for testing
those drugs in clinical trials in Humans for safety and
therapeutic effect.

7. • The sponsor will submit an application for conducting clinical
trials in human to FDA or DCGI.
• Once IND is submitted the sponsor must wait for 30 days
before initiating any trials
• Clinical trials in human can only begin when IND reviewed by
FDA and institutional review board[IRB].
• After that IRB approved clinical trials protocol
• Then further step will take like consent form from human
subjects to prevent them from harm.

8. Two categories of INDs
• 1.comercial
• 2.Non commercial [research]
• These are 3 types of INDs
• 1. An Investigator IND is submitted by a physician who both initiates
and conducts an investigation, and under whose immediate direction
the investigational drug is administered or dispensed. A physician
might submit a research IND to propose studying an unapproved
drug, or an approved product for a new indication or in a new patient
population.
• 2.Emergency use IND-Allows the FDA to authorize use of an
experimental drug in an emergency situation that does not allow
time for submission of an IND in accordance with 21CFR , Sec.
312.23 or Sec. 312.20. It is also used for patients who do not meet
the criteria of an existing study protocol, or if an approved study
protocol does not exist.

9. .
• 3. Treatment IND is submitted for experimental drugs showing
promise in clinical testing for serious or immediately life-
threatening conditions while the final clinical work is conducted
and the FDA review takes place.
• An IND application must contain information in 3 broad area;-
1. Animal Pharmacology and Toxicology Studies.
2. Manufacturing Information - Composition, manufacturer,
stability, and control.
3. Clinical Protocols and Investigator Information.

10. IND process in india
1
• Application of IND will receive at CDSCO
headquarter in new Delhi.
2
• 2.Then the application is reviewed by IND
committee after that committee submit it report to.
3
• To DCGI along with recommendation.if it is in
favourable condition then DCGI approved the IND

11. New drug application
• This application is file when an IND successfully pass through
all the three phases.
• Any new drug , the composition of which is such that it is not
recognized among experts qualified by scientific training as
safe and effective for use under prescribed, recommended or
suggested conditions.
• The NDA application is the vehicle through which drug
sponsors formally propose that the FDA approve a new
pharmaceutical for sale and marketing in the U.S.

12. Goal of NDA
• The NDA provide enough information to permit
FDA reviewer to reach safety, efficacy and quality
for pharmaceutical production.
• To make possible for new product to come in the
market easily with follow all the rules and
regulation which comes under FDA.
• To check weather the product is following all the
guidelines related to safety ,efficacy and quality.
• NDA is file after successfully completion of all 3
phases.

13. Classification of NDA
• NEW Molecular Entity.
• New Salt of Previously Approved Drug (not a new
molecular entity).
• New Formulation of Previously Approved Drug (not a
new salt OR a new molecular entity) .
• New Combination of Two or More Drugs.
• Already Marketed Drug Product - Duplication (i.e.,
new manufacturer).
• New Indication (claim) for Already Marketed Drug
(includes switch in marketing status from
prescription to OTC).
• Already Marketed Drug Product - No Previously
Approved NDA

14. Classification of NDA
NDA
New molecular
entity
New Salt of
Previously
Approved Drug
New Formulation
of Previously
Approved Drug
New Combination
of Two or More
Drugs
New Indication
(claim) for Already
Marketed Drug

15. NDA review process

16. summary
• Applicant –those who file NDA
• If application is up to the mark then it will go for further
verification process.
I. It will review by CDER among following parameters;-
pahrmacology,chemistry,statistics,microbiology,pharmace
utical,medical,reports from non clinical studies.
II. Then if all the given information is correct and up to the
mark then it will again review . And if not then it will go
for the required information whatever is not given or
which is required. like labelling review and sites
inspection review.
III. After all the reviews then it will allow to come in the
market.

17. General consideration of NDAs
• The applicant need to submit following things for the review to
CDER;-
• DMF [drug master file]-A document containing information regarding
API,excipients,area,packaging and etc.
• Document for stability of human drug and biologics
• Providing clinical evidence for of effectiveness for human drug and
biologics product.
• Impurities in drug substance
• Bioavailability and bioequivalence studies.
• Format and content of chemistry, Manufacturing and Control
,microbilogy,pharmacology and toxicology studies,statistical
studies,clinical and non clinical studies.
• Container closure system for packaging human and biollogics product

18. There are three types of FDA approval
process
Fast track approval
Priority review
Accelerated approval

19. Fast track approval
• To make new drug rapidly available in the market
• which show promise in treating a serious or life-
threatening disease and address an unmet medical need.
• Having some advantage over available treatment.
• Showing superior effectiveness
I. Avoiding serious side effects of an available treatment
II. Improving the diagnosis of a serious disease where early
diagnosis results in an improved outcome
III. Decreasing a clinically significant toxicity of an available
treatment
IV. Addressing an expected public health need.

20. Priority review
• It is a program of USFDA. to expedite the review
process for drugs that are expected to have a
particularly great impact on the treatment of a disease
• The goal of completing the review process in 6 month.
• It can given for both serious or non serious drugs
• The distinction between priority and standard review
times is that additional FDA attention and resources
will be directed to drugs that have the potential to
provide significant advances in treatment.

21. .
• Thank you