Pharma Industry Perspectives

Question 1

Pharma manufaturing laboratory

Answer 1

1. Research
2. Production
3. Quality control
4. Ditribution or Marketing

Question 2

Creation of new drugs for new products

Answer 2

Research

Question 3

May be intentionally or accidentally produced from natural sources or by chemical synthesis

Answer 3

New Drugs

Question 4

Play a role in the fomulation of the most suitable dosage forms
Determine the route of administration
Stability, mode of action and release at the intended site

Answer 4

Pharmacist in research

Question 5

1- lead compound selection

Answer 5

Identifying a promising compound

Question 6

2- discovery testing

Answer 6

Compound design and testing

Question 7

3- pre clinical research

Answer 7

Safety testing in lab animals

Question 8

3- manufacture research

Answer 8

Technical development

Question 9

4- investigational new drug (IND) application

Answer 9

Assessing safety of testing in humans

Question 10

5- clinical trials
Phase I, phase II, phase III

Answer 10

Safety and efficacy testing

Question 11

6- new drug application
(NDA)

Answer 11

Assessing the safety and efficacy for marketing

Question 12

7- postarketing surveilance

Answer 12

Safety and efficacy in general population
Pharmacovigilance

Question 13

Phase 0

Answer 13

Exploratory, to establish if agent will work as desired

Question 14

Phase 1

Answer 14

Determine basic pharmacological and toxocological info in humans especially on safety

Question 15

Phase 2

Answer 15

Conducted on a larger number of patients to further evaluate the safety of the treatment and to determine how well it works

Question 16

Phase 3

Answer 16

Involves a large number of patients to assess the risks and benefits

Question 17

Phase 4

Answer 17

Post marketing study to determine if drug works over time and if it works for the purpose other than what it was intended for

Question 18

Preclinical

Answer 18

3.5 - 6.5 years
Laboratory and animals studies
Assess safety and biological activity
5,000 compounds evaluated

Question 19

File IND with FDA

Answer 19

In between preclinical and phase 1

Question 20

Phase 1

Answer 20

1 - 1.5 years
20 - 80 healthy volunteers
Determine the safety and dosage

Question 21

Phase 2

Answer 21

2 years
100 - 300 patient volunteers
Evaluate effectiveness, look for side effects
5 enter clinical trials

Question 22

Phase 3

Answer 22

3 - 3.5 years
1,000 - 3,000 patient volunteers
Confirm effectiveness, monitor adverse reactions for long term use

Question 23

File NDA with the FDA

Answer 23

After phase 3

Question 24

Inside FDA

Answer 24

1.5 - 2.5 years
Review, process, approval
1 approved

Question 25

Phase 4

Answer 25

Additional post-marketing testing

Question 26

Drug development process

Answer 26

15 years

Question 27

Products sold under a brand name by owner of patent

Answer 27

Patented drug products

Question 28

Raw materials to finished products

Answer 28

Production

Question 29

Link between research and production

Answer 29

Pilot plant

Question 30

Raw materials, the intermediate, and finished products are subjected to qualitative/quantitative check for control purposes

Answer 30

Quality control

Question 31

Detailmen Personally contacting potential prescribers, pharmacists regarding their company's products

Answer 31

Distribution/Marketing

Question 32

Maintenance or improvement of health Via prevention, diagnosis, treatment

Answer 32

Healthcare

Question 33

State of complete physical, mental and social well being and not merely the absence of disease or infirmity

Answer 33

Health

Question 34

Person's perception of how he/she feels

Answer 34

Illness

Question 35

Judgement of one's state of health by medical professional

Answer 35

Disease

Question 36

Proportion of illness in a population

Answer 36

Morbidity

Question 37

Incidence of death in a population

Answer 37

Mortality

Question 38

Very dynamic, complex & challenging Multinational companies dominate the industry

Answer 38

Phil phamaceutical market

Question 39

Women tend to live longer than men by

Answer 39

5 years

Question 40

Morbidity 10 leading causes

Answer 40

TB Dengue fever TB respiratory Acute watery diarrhea Influenza UTI Bronchitis Hypertension ALRTI & Pneumonia Acute respiratory infection

Question 41

Mortality 10 leading Causes

Answer 41

Heart disease Disease of vascular system Malignant neoplasms (cancer) Pneumonia Accidents Diabetes mellitus Chronic lower respiratory diseases TB all forms Nephritis, nephrotic syndrome, nephrosis Condition originating from perinatal period

Question 42

Top pharma company in ph

Answer 42

Unilab Pfizer Abbot laboratories Glaxosmithkline Boeringer ingelheim Sanofi aventis Novartis Roche Merck sharo and dohme Bayer

Question 43

Most important development in the pharma industry

Answer 43

Formulation of PNDP(DRUG POLICY) Signing into law Generic Drug Act of 1988 now known as RA 6675

Question 44

Make essential drugs available, accessible, and affordable to the people

Answer 44

Goal of PNDP

Question 45

4 pillars of PNDP

Answer 45

Quality assurance Rational drug use Self reliance Tailored procurement

Question 46

An act to promote, require, and ensure the production of an adequate supply, distribution, use and acceptance of drugs/medicines by their generic names

Answer 46

RA 6675 Generics Act of 1988 Sept 13, 1988

Question 47

Full implementation of generics act

Answer 47

Generic labeling Generic advertising Generic prescribing Generic prescribing for single active ingredient, subsequently for multiple active ingredient products

Question 48

PNDF

Answer 48

Essential Drugs List or National Drug Formulary A list of drugs prepared & periodically updated by DOH

Question 49

List of drugs that meets the health care needs of the majority of the population

Answer 49

Core List

Question 50

List of alternative drugs other than the drugs form cor list

Answer 50

Complimemtary list

Question 51

Essential Medicines List

Answer 51

PNDF Volume 1

Question 52

Provided by medical professionals

Answer 52

Medical care

Question 53

Patients caring for themselves

Answer 53

Self care

Question 54

Precludes quidance from medical proffesionals Places an increased responsibility on pharmacists to analyze patients condition

Answer 54

Self Medication