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HISTORY AND VARIOUS PHASES OF DRUG DEVELOPMENT AND DRUG APPROVAL PROCESS

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HISTORY AND VARIOUS PHASES OF DRUG DEVELOPMENT AND DRUG APPROVAL PROCESS. Pool of Contents. History of drug development & drug approval process Various phases of drug development & drug approval process FDA’S Definitions of New Drug Treatment INDA References.

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slide1

HISTORY AND VARIOUS PHASES

OF DRUG DEVELOPMENT AND

DRUG APPROVAL PROCESS

pool of contents
Pool of Contents
  • History of drug development & drug approval process
  • Various phases of drug development & drug approval process
  • FDA’S Definitions of New Drug
  • Treatment INDA
  • References
fda s definition of new drug
FDA’S DEFINITION OF NEW DRUG
  • Is any that is recognized as being safe and effective in the conditions recommended for its use among experts who are qualified by scientific training and experience.
  • A drug need not to be NCE (new chemical entity) to be considered new.
  • Change in formulation ,mfg. method –bring change in therapeutic efficacy and /or safety.
  • A combination of two or more old drug or change in usual proportion of drug in an established combination product is considered new ,if it is safe & therapeutic efficious
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Cont…
  • A proposed new use for an established drug,a new dosage schedule or regimen , a new route of administration or a new dosage form all causes a drug status to new., if they safe and efficious.
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INDA
  • Under the F,D &Cosmetic Act as amended ,the sponser of a New drug is required to file with the FDA an IND before the drug may be given to human subjects.
  • This is to protect the rights and safety

Of the subjects and to ensure that the investigational plan is sound and is designed to achieve the stated objectives.

treatment inda
TREATMENT INDA
  • A treatment IND or a treatment protocols permit the use of an investigational drug in the treatment of patients not enrolled in the clinical study but who have a serious or immediately life threating disease for which there is no satisfactory alternative therapy.

e.g.: AIDS ,advanced metastasis refractory cancers, advanced multiple sclerosis, bacterial endocarditis

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NDA
  • If 3 phases of clinical testing during IND period demonstrate sufficient drug safety & therapeutic effectiveness ,the sponsor may file a NDA with a FDA.
  • Pre-NDA meeting b/w sponsor & FDA
  • the purpose of the NDA is to gain permission to market the drug.
continued
Continued……
  • Ansel’s Pharmaceutiocal Dosage forms and Drug delivery systems
  • www.fda.gov/cder/handbook/ndabox.htm
  • www.fda.gov
  • www.phrma.org
questions

??? Questions ????

DEFINE NEW DRUG AS PER FDA.

DISCUSS HISTORICAL BACK GROUND OF DRUG APPROVAL.

EXPLAIN THE BASIC DRUG APPROVAL PROCESS IN DETAIL.

EXPLAIN CLINICAL TRIALS IN BRIEF.

WHAT IS TREATMENT INDA?

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