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

1. 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.

2. Drug development team

3. Investigational new drug application (INDA)

4. Format and content of IND

5. Preclinical testing

6. The development process IND
application and safety

7. Clinical research

8. New drug application

9. Abbreviated new drug application

10. Changes to an approved NDA or ANDA

11. Difference between NDA and ANDA

1. Approval and application process involved in investigational new drug Presented by Irshad , Akill, Sahil, Rahul, Sachin B pharmacy 8 th 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: An investigator IND Emergency IND Treatment IND

6. Various Phases of Drug Development and Drug Approval Process

7. Format and Content of IND

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

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. 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

13. 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.

14. 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

15. Difference Between NDA & ANDA