CLINICAL TRIALS PHARMACOLOGY

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. 1/1000 TH 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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