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  • 2. 2 IND Applications To begin clinical studies on a drug product for human use, a sponsor (generally a pharmaceutical company or a research organization) must receive an exemption from FDA from Act’s provisions prohibiting distribution of new drugs not having approval from FDA.(21 U.S.C.335i)
  • 3. 3 Why IND Required If it is intended to support a 1) New indication 2) Change in approved route of administration or dosage level 3) Change in approved patient population e.g (pediatric) or a population at increased or greater risk (elderly,HIV +ve, immune compromised) 4) Significant change in promotion of an approved drug.
  • 4. 4 Types of IND 3 Types 1) Investigator IND 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.
  • 5. 5 Emergency use IND 1) 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. 312.34. 2) 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.
  • 6. 6 Treatment IND • 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.
  • 7. 7 Categories of IND Two categories 1) Commercial 2) Research (non commercial)
  • 8. 8 Role of FDA 1) FDA role in development of new drug begins When the drug sponsor (usually the mfgr or potential marketer) having screened the new molecule for pharmacological activity and acute toxicity potential in humans.
  • 9. 9 contd 2) Also wants to test it’s diagnostic or therapeutic potential in humans. 3) At that point the molecule changes in legal status under the FDA and cosmetic Act and becomes a new drug subject to specific requirements of the regulatory system.
  • 10. 10 How to get exemption from FDA The sponsor supplies the FDA with IND application containing; a) Information on Drug b) Protocols describing how the proposed clinical trials will be conducted.
  • 11. 11 IND APPLICATIONS must contain 3 broad areas 1) Animal Pharmacology and Toxicology Studies Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
  • 12. 12 Manufacturing Information a) Information pertaining to the composition, manufacturer, stability, controls used for manufacturing the drug substance and the drug product. b) This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
  • 13. 13 Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound-to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
  • 14. 14 Guidelines or Protocols for Application Application for IND exemption to FDA contain information's a) Cover sheet b) Introductory statement and general investigational plan
  • 15. 15 contd c) Drug Master files 1) Type 1 include Mnfg site, facilities, operating procedures and personnel. 2) Type 2 Drug substance, materials used in preparation or Drug product. 3) Type 3 Packaging material 4) Type 4 Excipients, colorant, Flavor, Essence or material used in their preparation or Drug product.
  • 16. 16 contd 5) Type 5 FDA accepted reference information d) Protocols outlying each study e) Pharmacology and Toxicology information’s f) Additional information's on drug dependence and abuse potential of the drug. (21CFR section 312.23)
  • 17. 17 Objective of FDA in Reviewing IND A) To assure safety and rights of objects in all phases of an investigation. B) In phases 2 & 3, to help assure that the quality of scientific evolution of the drug is adequate to permit an evaluation of drug effectiveness. ( 21 CFR 312.22)
  • 18. 18 THANKS