SlideShare a Scribd company logo
Presented by
Irshad, Akill, Sahil, Rahul, Sachin
B pharmacy
8th Semester
Under the Supervision of
Dr . S.C. Arora
Principal
R.K.S.D. College of Pharmacy,
Kaithal (Haryana)
Content
 Introduction
 Drug development team
 Investigational new drug application (INDA)
 Format and content of IND
 Preclinical testing
 The development process IND application and safety
 Clinical research
 New drug application
 Abbreviated new drug application
 Changes to an approved NDA or ANDA
 Difference between NDA and ANDA
Introduction
 During a new drug's early preclinical development, the
sponsor's primary goal is to determine if the product is
reasonably safe for initial use in humans, and if the
compound exhibits pharmacological activity that
justifies commercial development. When a product is
identified as a viable candidate for further
development, the sponsor then focuses on collecting
the data and information necessary to establish that
the product will not expose humans to unreasonable
risks when used in limited, early-stage clinical studies.
Drug Development team
 Drug development is the process bringing a new drug
molecule into clinical practice
Investigational new drug
application (INDA)
 INDA is a request for authorization from the government authority like Food
and Drug administration (FDA) to administer an investigational drug or
biological product to human i.e. to start clinical trials. FDA's role in
development of new drug begins when drug sponsor want to test activities of
drug in human and apply to FDA in terms of INDA. The INDA also allows the
company to transport or import of unapproved drug legally.
There are two categories of IND
1.Commercial
2.Reasearch
The IND application must contain information in three broad areas:
1.Animal pharmacology and toxicology studies
2.Manufacturing Information
3.Clinical protocols and Investigator Information
Application are of three types:
1. An investigator IND
2. Emergency IND
3. Treatment IND
Various Phases of Drug Development and Drug Approval Process
Format and Content of IND
Cover Sheet
Table of Content
Introductory Statement and General InvestigatIon Plant
Investigator Brouchre
Protocol
Chemistry Manufacturing and Control Information
Previous Human Experience wiih the investigational Drug
Additional Information
Pre Clinical Testing
 (Lab and animal testing to determine safety of drug for
human trials) Testing at this stage can take from one to five
years and must provide information about the
pharmaceutical composition of the drug, its safety, how the
drug will be formulated and manufactured, and how it will
be administered to the first human subjects. Scientists
carryout in vitro and in vivo tests. In vitro tests are
experiments conducted in the lab, usually carried out in
test tubes and beakers ("vitro" is "glass" in Latin) and in
vivo studies are those in living cell cultures and animal
models ("vivo" is "life" in Latin).Scientists try to
understand how the drug works and what its safety profile
looks
The Development Process
Investigational New Drug
Application and Safety
 Before any clinical trial can begin, the researchers must file an
Investigational New Drug (IND) application with the FDA. The application
includes the results of the preclinical work ,the candidate drug's effects and
manufacturing information. The IND also provides a detailed clinical trail
plan that outlines how, where and by whom the studies will be performed
 The FDA or the sponsor company can stop the trial at any time if
problems arise. Finally, the company sponsoring the research must provide
comprehensive regular reports to the FDA and the IRB on the progress of
clinical trials.
Clinical Research
Phase 1
• Human
Pharmacology
• Safety, PK,
Tolerability
• 20-100
Healthy
Volunteer
Phase 2
• Therapeutic
Exploratory
• Safety, Efficacy
• 100-500
patient
Phase 3
• Therapeutic
Confirmatory
• Safety, Efficacy
• 1000-5000
patient
New Drug Application
 Once all three phases of the clinical trials are
completed, the sponsoring company analyzes all of the
data. If the findings demonstrate that the
experimental medicine is both safe and effective, the
company files a New Drug Application (NDA), which
can run 1000 pages or more.
New Drug Application
 The NDA application is the vehicle through which
sponsor formally propose that the FDA approve a new
pharmaceutical for sale and marketing In U.S. The
data gathered during animal Studies and human
clinical Trials of an part of the NDA
 An ANDA contains data which is submitted to for the
review and potential approval of a generic drug
product. Once approved an applicant may
manufacture and market the generic drug to provide
Safe, effective, Lower lost alternatives. To the brand-
name drug it references.
Changes to an Approved NDA
or ANDA
 FDA has categorized changes in three types
 Major Changes
 It is a change that has a considerable potential to have an adverse effect on
the identity , strength, quality purity of a drug product as these as the factors
may relate to the safety or effectiveness of the drug product
 Moderate Changes
 It is a change that has a moderate potential to have an adverse effect on the
identity , strength, quality purity of a drug product as these as the factors
may relate to the safety or effectiveness of the drug product
 Minor Changes
 It is a change that has a Minimal potential to have an adverse effect on the
identity , strength, quality purity of a drug product as these as the factors
may relate to the safety or effectiveness of the drug product
Difference Between NDA & ANDA
NDA
• Applicable for New
Drug
• Take Longer time (12-
15 Years)
• More Expenditure of
Money
• Cost of Drug are more
ANDA
• Applicable for
Generic Drug
• Less Time (1-2) Years
• Comparatively Less
• Cost of Drug is less
Approval and Application Process involved in Investigational New Drug (IND)
Approval and Application Process involved in Investigational New Drug (IND)

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Approval and Application Process involved in Investigational New Drug (IND)

  • 1. Presented by Irshad, Akill, Sahil, Rahul, Sachin B pharmacy 8th Semester Under the Supervision of Dr . S.C. Arora Principal R.K.S.D. College of Pharmacy, Kaithal (Haryana)
  • 2. Content  Introduction  Drug development team  Investigational new drug application (INDA)  Format and content of IND  Preclinical testing  The development process IND application and safety  Clinical research  New drug application  Abbreviated new drug application  Changes to an approved NDA or ANDA  Difference between NDA and ANDA
  • 3. Introduction  During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
  • 4. Drug Development team  Drug development is the process bringing a new drug molecule into clinical practice
  • 5. Investigational new drug application (INDA)  INDA is a request for authorization from the government authority like Food and Drug administration (FDA) to administer an investigational drug or biological product to human i.e. to start clinical trials. FDA's role in development of new drug begins when drug sponsor want to test activities of drug in human and apply to FDA in terms of INDA. The INDA also allows the company to transport or import of unapproved drug legally. There are two categories of IND 1.Commercial 2.Reasearch The IND application must contain information in three broad areas: 1.Animal pharmacology and toxicology studies 2.Manufacturing Information 3.Clinical protocols and Investigator Information Application are of three types: 1. An investigator IND 2. Emergency IND 3. Treatment IND
  • 6. Various Phases of Drug Development and Drug Approval Process
  • 7. Format and Content of IND Cover Sheet Table of Content Introductory Statement and General InvestigatIon Plant Investigator Brouchre Protocol Chemistry Manufacturing and Control Information Previous Human Experience wiih the investigational Drug Additional Information
  • 8. Pre Clinical Testing  (Lab and animal testing to determine safety of drug for human trials) Testing at this stage can take from one to five years and must provide information about the pharmaceutical composition of the drug, its safety, how the drug will be formulated and manufactured, and how it will be administered to the first human subjects. Scientists carryout in vitro and in vivo tests. In vitro tests are experiments conducted in the lab, usually carried out in test tubes and beakers ("vitro" is "glass" in Latin) and in vivo studies are those in living cell cultures and animal models ("vivo" is "life" in Latin).Scientists try to understand how the drug works and what its safety profile looks
  • 9. The Development Process Investigational New Drug Application and Safety  Before any clinical trial can begin, the researchers must file an Investigational New Drug (IND) application with the FDA. The application includes the results of the preclinical work ,the candidate drug's effects and manufacturing information. The IND also provides a detailed clinical trail plan that outlines how, where and by whom the studies will be performed  The FDA or the sponsor company can stop the trial at any time if problems arise. Finally, the company sponsoring the research must provide comprehensive regular reports to the FDA and the IRB on the progress of clinical trials.
  • 10. Clinical Research Phase 1 • Human Pharmacology • Safety, PK, Tolerability • 20-100 Healthy Volunteer Phase 2 • Therapeutic Exploratory • Safety, Efficacy • 100-500 patient Phase 3 • Therapeutic Confirmatory • Safety, Efficacy • 1000-5000 patient
  • 11. New Drug Application  Once all three phases of the clinical trials are completed, the sponsoring company analyzes all of the data. If the findings demonstrate that the experimental medicine is both safe and effective, the company files a New Drug Application (NDA), which can run 1000 pages or more.
  • 12.
  • 13. New Drug Application  The NDA application is the vehicle through which sponsor formally propose that the FDA approve a new pharmaceutical for sale and marketing In U.S. The data gathered during animal Studies and human clinical Trials of an part of the NDA
  • 14.
  • 15.  An ANDA contains data which is submitted to for the review and potential approval of a generic drug product. Once approved an applicant may manufacture and market the generic drug to provide Safe, effective, Lower lost alternatives. To the brand- name drug it references.
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  • 17. Changes to an Approved NDA or ANDA  FDA has categorized changes in three types  Major Changes  It is a change that has a considerable potential to have an adverse effect on the identity , strength, quality purity of a drug product as these as the factors may relate to the safety or effectiveness of the drug product  Moderate Changes  It is a change that has a moderate potential to have an adverse effect on the identity , strength, quality purity of a drug product as these as the factors may relate to the safety or effectiveness of the drug product  Minor Changes  It is a change that has a Minimal potential to have an adverse effect on the identity , strength, quality purity of a drug product as these as the factors may relate to the safety or effectiveness of the drug product
  • 18. Difference Between NDA & ANDA NDA • Applicable for New Drug • Take Longer time (12- 15 Years) • More Expenditure of Money • Cost of Drug are more ANDA • Applicable for Generic Drug • Less Time (1-2) Years • Comparatively Less • Cost of Drug is less