LINK FOR VIDEO LECTURE https://youtu.be/TnIlNoxbpXg THIS SLIDE SHARE IS ALL ABOUT CLINICAL TRIALS AND ITS DIFFERENT PHASES . IT HELPS PHARMACY AS WELL AS OTHER MEDICAL AND RESEARCH STUDENTS .

1. CLINICAL TRIAL
(PHARMACOLOGY)
BY MUKUL ARORA
FOUR TIMES GPAT QUALIFIED
QUALIFIED NIPER IN 2018
QUALIFIED GATE(XL) IN 2020.

2. Video lecture link is in description
• YOU CAN ALSO SEARCH “PHARMA
POWER”ON YOUTUBE .

3. PRE-CLINICAL TRIAL
• Before any drug comes to market ,it is tested in
animals and in-vitro studies are done for safety and
efficacy .
• IN PRE-CLINICAL TRIAL whole
PHARAMACOLOGICAL PROFILE test are performed
on the ANIMALS (RAT,MICE,GUINEA PIG ).
• THAN ON THE LARGE ANIMALS
(CAT,DOG,MONKEY).
• If the drug is found SAFE than it is send for clinical
trial.

4. CLINICAL TRAILS
• IF the drug is found safe in pre-clinical trial,
then a application is filled to U.S FDA .
• The application is
• IND-INVESTIGATIONAL NEW DRUG
• If U.S FDA give permission then we can perform
clinical trials.
• Clinical trial is performed on the humans to
know the pharmacokinetic ,pharmacodynamics
,toxicology, therapeutic index etc.

5. PHASE 0 (MICRODOSING STUDIES )
• DONE TO AVOID COSTLY PHASE -1 STUDIES.
• 1/1000TH of human dose is given .
• (maximum 10micrograms )
• Drug is given to healthy volunteers .
• Dose is sub-therapeutic.
• Safety and efficacy cannot be know in the
phase 0.

6. PHASE 1
(HUMAN PHARMACOLOGY AND SAFETY)
• FIRST STUDY IN HUMANS.
• NORMAL HUMAN VOLUNTEERS .
• 20-100 VOLUNTEERS .
• OPEN LABEL.
• ELDER AND CHILDREN ARE EXCLUDED .
• DO NOT TETSED IN THE PATIENCE .
• OBJECTIVE- TO KNOW MAXIMUM
TOLERABLE DOSE .(MTD)
• TOXICITY AND PHARMACOKINETIC STUDY .

7. IMORTANT POINT OF PHASE 1
• IF ANY ANTI-CANCER ARE TETSED ON
PATIENTS IN PHASE 1.
• THEN, IT IS TESTED ON THE PATIENTS NOT
ON HEALTHY INDIVIDUALS .
• DUE TO ITS TOXICITY IN HEALTHY
INDIVIDUALS .

8. PHASE 2(THERAPEUTIC EXPLORATORY)
• TESTED ON THE PATIENTS . (ONE CENTRE)
• 100-150
• FIRST STUDY IN THE PATIENTS .
• HOMOLOGOUS PATIENTS .(SAME GENETIC
MAKE UP.
• SINGLE BLIND (CONTROLLED )
• OBEJECTIVE-
• TO ESTABLISH THERAPEUTIC EFFICACY .
• DOSE RANGING AND CEILING EFFECT .

9. PHASE 3
(THERAPEUTIC CONFIRMATORY)
• LARGE NUMBER OF PATIENTS AT SEVERAL
CENTRE .
• TESTED ON THE PATIENTS .
• HETEROGENOUS POPULATIONS
(DIFFERENT GENETIC MAKE UP).
• UPTO 5000 PATIENTS .
• DOUBLE BLIND (RANDOMIZED
CONTROLLED ).

10. IMPORTANT POINTS
• OBJECTIVE – TO CONFIRM THERAPEUTIC
EFFICACY .
• TO ESTABLISH VALUE OF DRUG IN
RELATION TO THE EXISTING THERAPY.
• IF DRUG IS FOUND SAFE AND EFFECTIVE .
• APPLICATION (NDA)-NEW DRUG
APPLICATION IS FILLED TO U.S FDA .

11. PHASE 4 (POST –MARKET SURVILLANCE)
• IF APPROVAL IS GRANTED ,DRUG IS
MARKETTED .
• SPECIAL GROUPS LIKE
CHILDREN,PREGNANT WOMEN,ELDER ARE
INCLUDED OR TESTED .
• OBJECTIVE –
• TO KNOW THE RARE SIDE EFFCTS OR
WITHDRWAL SYMPOTMS
• TO KNOW LONG TERM USE OF DRUG AND
SIDE EFFECTS .

12. TIME PERIOD OF CLINCIAL TRIALS
PRE-CLINICAL TRAIL 1.5-2 YEARS
PHASE 1 TO PHASE 3 5-7 YEARS
NDA 1-4.5 YEARS
PHASE 4 UPTO 4 YEARS
(REPORT -2YEARS )

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