DRUG DISCOVERY AND CLINICAL TRIALS

Question 1

WHAT ARE THE STAGES OF DEVELOPMENT OF A NEW DRUG

Answer 1

1. BASIC RESEARCH DRUG DISCOVERY
2. PRE CLINICAL DEVELOPMENT/ RESEARCH
3. PHASE 1 CLINICAL DEVELOPMENT
4. PHASE 2 CLINICAL DEVELOPMENT
5. PHASE 3 CLINICAL DEVELOPMENT
6. REGULATORY REVIEW
7. CONTINUOUS REVIEW

Question 2

WHAT GOES ON IN BASIC RESEARCH DRUG DISCOVERY

Answer 2

CANDIDATE MOLECULES ARE CHOSEN ON THE BASIS OF THEIR PROPERTIES FROM LARGE LIBRARIES

Question 3

HOW LONG DOES THE BASIC RESEARCH DRUG DISCOVERY PHASE AND PRE CLINICAL DEVELOPMENT/ RESEARCH PHASE LAST

Answer 3

3-6 YEARS

Question 4

WHAT GOES ON IT PRE CLINICAL DEVELOPMENT/ RESEARCH

Answer 4

A WIDE RANGE OF NON HUMAN TESTS ARE PERFORMED INCLUDING TOXICITY AND PHARMACOKINETICS

Question 5

WHAT GOES ON IN PHASE 1 CLINICAL DEVELOPMENT

Answer 5

PHARMACOKINETICS, TOLERABILITY, SIDE EFFECTS IN HEALTHY HUMAN VOLUNTEERS

Question 6

WHAT GOES ON IN PHASE 2 CLINICAL DEVELOPMENT

Answer 6

SMALL SCALE TRIALS IN PATIENTS TO ASSESS EFFICACY AND DOSAGE OF LONG TERM TOXIOCOLOGY STUDIES

Question 7

WHAT GOES ON IN PHASE 3 CLINICAL DEVELOPMENT

Answer 7

LARGE SCALE TRIALS TO EVALUATE HOW NEW MEDICATION WORKS COMPARED TO EXISTING ONES

Question 8

HOW LONG DO CLINICAL TRIALS TAKE

Answer 8

6-7 YEARS

Question 9

WHAT GOES ON IN REGULATORY REVIEW

Answer 9

WHICH COUNTRIES/AUTHORITIES WANT THE PRODUCT

Question 10

HOW LONG DOES REGULATORY REVIEW TAKE

Answer 10

6 MONTHS - 2 YEARS

Question 11

WHAT GOES ON IN CONTINUOUS REVIEW

Answer 11

REPORTS FROM PATIENTS AND GPS OF PATIENTS OF SIDE EFFECTS FED BACK IN A LOOP

Question 12

WHY IS REGULATION OF DRUGS NEEDED

Answer 12

FOR THE PROTECTION AND HEALTH OF THOSE TAKING THE DRUGS

Question 13

EXAMPLES OF REGULATORY AUTHORITIES

Answer 13

FDA
ANVISA
EUROPEAN MEDICINES AGENCY
CFDA

Question 14

EXAMPLE OF WHY REGULATION IS NEEDED

Answer 14

THALIDOMIDE (1962)
SEVERE DEFECTS IN 10-20 THOUSAND BABIES

SULPHATHIAZOLE TABLETS (1941)
LACK OF CONTROL TESTS CAUSED 300 DEATHS

Question 15

WHAT HAPPENS IN STAGES 1 AND 2 OF DEVELOPMENT OF DRUGS

Answer 15

1. RESEARCH IS FOUND IN UNIVERSITIES/RESEARCH CENTRES TO FIND A TARGET SELECTION
2. MULTIPLE LEADS ARE FOUND USING LIBRARIES OF MILLIONS OF DRUGS AGAINST THE RECEPTOR ASSAYS RUNNING
3. EXPLORATORY TOXICOLOGY AND SAFETY EXPERIMENTS ARE DONE ON THESE LEADS TO NARROW DOWN THE LEADS MOVING FORWARDS

Question 16

WHAT TYPES OF TESTS ARE IN THE EXPLORATORY TOXICOLOGY AND SAFETY EXPERIMENTS

Answer 16

GENETOTOXICITY
MUTAGENICITY
CV AND CNS SAFETY

AMES TEST
hERG K ION CHANNEL BIOMARKERS

Question 17

WHAT TYPES OF TESTS ARE DONE IN THE REGULATORY TOXICOLOGY AND SAFETY EXPERIMENTS

Answer 17

HAEMATOLOGY
KIDNEY/LIVER FUNCTION
COAGULATION
ORGAN TOXICITY
CV/CNS SAFETY - WHOLE BODY PLETHYSMOGRAPHY, IRWIN ACTIVITY SCREEN, ECG
PROVIDE SAFETY MARGIN
DEFINE DOSE/CONC AND TIME COURSE/DOSE
DEFINE MAX DOSE
TARGET ORGANS/RESCUE TREATMENTS
OBTRAIN REGULAROTY APPROVAL FOR CLINICAL TRIALS

Question 18

BEFORE CLINCAL TRIALS CAN PROCEED:

Answer 18

EVIDENCE OF PHARMACOLOGICAL ACTIVITY
MAXIMUM NON TOXIC DOSE
ADVERSE EFFECTS ON TARGET ORGANS
DOSE/EXPOSURE RELATIONSHIP
DIFFERENCES IN SPECIES
EVALUATION OF RISK IN HUMANS

Question 19

IN WHICH PHASE DO MOST DRUGS FAIL

Answer 19

PHASE 2 CLINICAL TRIALS