PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER QUALITY ASSURANCE

1. IND APPLICATION FORM.
BY,
VENKATESH PRASATH.N
M.PHARM QA.
JSSCP,OOTY

2. INTRODUCTION.
What is an IND?
• Investigational New Drug is meant by which pharmaceutical company
obtain permission to start human clinical trials.
• It also provides the data shows it is reasonable to test drugs on
humans.
• It acts as a vehicle to sponsor to next stage of drug development as
clinical trials.
• It shows the results of previous experiments,
Chemical structure of compound and its manufacturing.
• Toxic effects in the animal studies.
• How, where and by whom new studies will be conducted.

3. Classification of IND.
COMMERCIAL – It permit sponsor to
collect clinical safety and
effectiveness data for application for
marketing
RESEARCH ( non-commercial) – It
permits sponsor to use drug for
research for scientific knowledge of
new drug no plan to market the
product.

4. Type’s of IND application's.
Investigator IND
application
• A physician might
submit a research
IND application to
propose study of
• An unapproved
drug,
• An approved
product with new
indications,
• An approved
product in new
patient
population.
Emergency use IND
application
• Applicant allow
the FDA to
authorize use of
experimental drug
in emergency
situations does
not allow time for
submission of IND
application. 21
CFR 312.23.
Treatment IND
application
• Application
should be
submitted for
experimental
drugs showing
promise in clinical
testing for serious
or immediately
life threatening
conditions and
not approved for
market.
Screening IND
application
• filed for multiple
or closely related
compounds in
order to screen
for the preferred
compounds or
formulations.

5. Contents of IND applications:
1. Animal pharmacology and toxicology studies.
2. Manufacturing information.
3. Clinical protocols and investigator information.

8. IND Review & Report
FDA has opportunity to review the IND application for safety to assure research subjects
not subjected to unreasonable risk.

9. INTRO:
• The NDA application is the vehicle through which drug
sponsors, formally propose that FDA approve a new
pharmaceutical for sale and marketing.
• The data gathered during the animal studies and human
clinical trials of an IND becomes part of NDA.
• Since 1938,every new drug or therapy has been the
subject of an approved NDA before US
commercialization.
• The documentation required in an NDA is supposed to
tell the drug’s whole story including what happened
during clinical trials, what the ingredients of the drug
are, the animal studies, how the drug behaves in the
body, and hoe it is manufactured, processed and
packed.

10. OBJECTIVES OF NDA
• Whether the drug is safe and effective in its
propose use, and whether the benefits of the drug
outweigh the risks.
• Whether the drug’s proposed labelling(package
inert) is appropriate , and what it should contain.
• Whether the methods used in manufacturing the
drug and the controls used to maintain the drug’s
quality are adequate to preserve the drug’s quality
are adequate to preserve the drug’s identity,
strength, quality and purity

11. NDA FORM
• Form FDA -356h. Application to market a new drug,
biological or an antibiotic drug for human use.
• Form FDA 3397.user fee cover sheet.
• Form FDA 3331. new drug application field report.
• Code of federal regulation title 21 section 314 (21
CFR 314) is provided a brief description for NDA and
ANDA.

12. NDA REVIEW PROCESS

16. NDA ANDA
Applicable for new drug Applicable for generic drug
Take longer years (12 -15) years Compared to NDA ,less time taken(1-2)
years.
More expenditure of money Comparatively less
Cost of drugs are more Cost of drugs is less
Nonclinical studies and clinical
investigations are essential
Nonclinical studies and clinical
investigations are nonessential except
bioavailability and bioequivalence.