clinical developments in drug discovery process varoius phases of clinical trials Phase I, Phase II, Phase III

1. DRUG DISCOVERY
PRESENTED BY
AISWARYA.G
FIFTH YEAR PHARM.D
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3. The clinical research (IND) phase—representing the
time from beginning of human trials to the new drug
application (NDA) submission that seeks permission
to market the drug—is by far the longest portion of
the drug development cycle and can last from 2 to 10
years.
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4. CLINICAL DEVELOPMENT
Investigational New Drug (IND)application in India,US,and
Clinical Trial Authorization (CTA) in Australia and UK are
examples of requests ,which are submitted to appropriate
regulatory authorities for permission to conduct investigational
research.
Clinical evaluation of an investigational new drug begins only
after permission to begin administration in healthy volunteers or
patient is granted .
It also involves evaluation of a new dosage form or new use of a
drug already approved for marketing.
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5. In addition to obtaining permission from
appropriate regulatory authorities ,an Institutional
or Independent Review Board (IRB) or
Independent Ethics Committee must approve the
study protocols as well as the Informed Consent
Documents (ICD) along with applicable translated
version of ICDs in relevant languages .
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6. CLINICAL
DEVELOPMENT
PHASE 1
PHASE 2
PHASE 3
Each phase has different objective and in each successive phase, increasing
number of patients are enrolled .
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8. PHASE 1 CLINICAL STUDIES
•To verify safety and tolerability of the candidate drug in
humans and find out maximum tolerated dose (MTD).
•Takes about 6 -9 months and are the first studies
conducted in humans .
•20-100 healthy volunteers take investigational drugs for
a short period of time.
•Testing includes observation and careful documentation
of pharmacodynamic and pharmacokinetic properties of
the drug.
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10. PHASE 2 CLINICAL STUDIES
•Determines the effectiveness and further study the safety of the
Investigational New Drug in humans and establishes the minimum and
maximum effective doses.
•Depending upon the new drug and the condition it treats ,this phase
generally takes from 6 months to 3 years .
•Several 100 patients suffering from the condition the investigational drug
is designed to treat .
•Usually phase 2 clinical trials are randomized study in which the patients
are randomly divided into groups ,one which receives the investigational
drugs and the other gets placebo( containing no medication) and
sometimes a third that receives a current standard treatment to which the
investigational drug will be compared.
•Most of the phase 2 studies are randomized and double blinded.
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12. PHASE 3 CLINICAL STUDIES
•Conducted in large patient population to assess the efficacy and
safety of an investigational drug.
•Randomized and double blinded study.
•Depending upon the type of new drug and the condition it treats
,this phase usually requires 1-4years of evaluation.
•100-1000patients
•Investigational drug is compared with one of the currently
available standard treatments .
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15. NEW DRUG APPLICATION
(NDA)/MARKETING AUTHORIZATION
APPLICATION(MAA)
NDAs (in India,US) and MAAs (in UK) are examples of
applications,which are submitted to regulatory agencies
in these countries for obtaining approval to market a new
drug.
These application document safety and efficacy of the
investigational drug and contain all information collected
during the drug development process.
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16. At the conclusion of successful preclinical and clinical
evaluation ,all documents are submitted to “The Drug Controller
General Of India” or”the FDA in the U.S.” or to “The applicable
regulatory authorities in other countries”.
Substantial evidence is presented that the drug will have the
desired efficacy and safety in the disease condition for which it
has been developed.
It takes 6months -2 years to take the marketing authorization
and varies from country to country.
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17. THANK YOU
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