2. DRUG DEVELOPMENT
Development of a new
therapeutic drug is a
complex, lengthy and
expensive process
2
expensive process
costs nearly huge amount and
an average of 15 years.
4. Introduction
• Investigational new drug (IND)
It’s deals with a new chemical entity, which will
be tested for obtaining evidence of safety and
effectiveness in accordance with the regulations.
• New drug application (NDA)
Is a document submitted to the regulatory
authorities for permission to market a new drug
product in that country.
4
6. To assure the safety and rights of subjects in
all phases of an investigation.
In phases 2 and 3, to help assure that the
quality of the scientific evaluation of the drug
Objectives
quality of the scientific evaluation of the drug
according to the -- (21 CFR 312.22).
• Code of Federal Regulations, part 312 (21 CFR
part 312) (the IND regulations).
6
7. TYPES OF IND
Investigator IND
o Submitted by a physician who both initiates and conducts an
investigation, and under whose immediate direction the
investigational drug is administered or dispensed.
o 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.
Emergency Use IND
7
Emergency Use IND
o Allows FDA to authorize use of an experimental drug in an
emergency situation .
o Does not allow time for submission of an IND in accordance
with 21CFR , Sec. 312.23 or Sec. 312.34
Treatment IND
o 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.
8. The IND application must contain :-
• In - vitro studies.
• Toxicology Studies.
• Chemical studies.
• Manufacturing Information .
• Clinical trail protocols.
• A review given by the institutional review board (IRB)
8
9. ApplicantDrug Sponsor
IND
Review by CDER
Medicinal chemistry Pharmacological Toxicological statistical
Safety Review Sponsor submits new data
Safety acceptable for Chemical hold decisionNoSafety acceptable for
study to proceed
Chemical hold decision
Complete reviews Notify Sponsor
Review complete & acceptable? Sponsor notified of deficiencies
No Deficiencies Study ongoing
No
No
No
Yes
Yes
Yes
Investigational New Drug Application (IND)
12. Provide enough information to permit FDA reviewers to
establish the following:
Safety & effectiveness of drug.
Benefits overweigh risks.
Risk Benefit
OBJECTIVES
12
Is the drug’s proposed labelling (package insert)
appropriate, and what should it contain?
Are the methods used in manufacturing (Good
Manufacturing Practice, GMP) the drug and the
controls used to maintain the drug’s quality
adequate to preserve the drug’s identity,
strength, quality, and purity?
13. NDA CONTENTS
1. Introduction
Brief description of the drug and the therapeutic class to which
it belongs
2. Chemical and pharmaceutical information
3. Animal Pharmacology
4. Animal Toxicology
5. Human/Clinical Pharmacology phase I
6. Therapeutic exploratory trials (Phase II)
13
6. Therapeutic exploratory trials (Phase II)
7. Therapeutic confirmatory trials (Phase III)
8. Special Studies
o Geriatrics, pediatrics, pregnant or nursing women
9. Regulatory status in other countries
10. Prescribing information
11. Samples and Testing Protocol/s
17. Requirements US INDIA
Application ANDANDA MAA
Debarment
Classification
Required Required
Number of
copies
3 1
Approval ~18 Months 12~18 Months
ADMINISTRATIVE REQUIREMENTSADMINISTRATIVE REQUIREMENTS
Approval
Time period
~18 Months 12~18 Months
Fees Approximately
$52,000 for
ANDA Application
&
Up to $2 million
for NDA
Application
50,000 INR
Presentation eCTD & Paper Paper
18. Requirements US INDIA
Justification ICH Q6A ICHQ6A
Assay 90-100% 90-110%
Disintegration Not Required Required
Colour Identification Not Required Required
18
Water Content Required Required
