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Pharmacy > Pharma Industry Perspectives > Flashcards

Pharma Industry Perspectives Flashcards

1
Q

Pharma manufaturing laboratory

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

Creation of new drugs for new products

A

Research

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3
Q

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

A

New Drugs

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4
Q

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

A

Pharmacist in research

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5
Q

1- lead compound selection

A

Identifying a promising compound

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6
Q

2- discovery testing

A

Compound design and testing

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7
Q

3- pre clinical research

A

Safety testing in lab animals

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8
Q

3- manufacture research

A

Technical development

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9
Q

4- investigational new drug (IND) application

A

Assessing safety of testing in humans

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10
Q

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

A

Safety and efficacy testing

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11
Q

6- new drug application
(NDA)

A

Assessing the safety and efficacy for marketing

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12
Q

7- postarketing surveilance

A

Safety and efficacy in general population
Pharmacovigilance

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13
Q

Phase 0

A

Exploratory, to establish if agent will work as desired

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14
Q

Phase 1

A

Determine basic pharmacological and toxocological info in humans especially on safety

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15
Q

Phase 2

A

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

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16
Q

Phase 3

A

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

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17
Q

Phase 4

A

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

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18
Q

Preclinical

A

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

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19
Q

File IND with FDA

A

In between preclinical and phase 1

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20
Q

Phase 1

A

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

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21
Q

Phase 2

A

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

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22
Q

Phase 3

A

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

23
Q

File NDA with the FDA

A

After phase 3

24
Q

Inside FDA

A

1.5 - 2.5 years
Review, process, approval
1 approved

25
Q

Phase 4

A

Additional post-marketing testing

26
Q

Drug development process

A

15 years

27
Q

Products sold under a brand name by owner of patent

A

Patented drug products

28
Q

Raw materials to finished products

A

Production

29
Q

Link between research and production

A

Pilot plant

30
Q

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

A

Quality control

31
Q

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

A

Distribution/Marketing

32
Q

Maintenance or improvement of health
Via prevention, diagnosis, treatment

A

Healthcare

33
Q

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

A

Health

34
Q

Person’s perception of how he/she feels

A

Illness

35
Q

Judgement of one’s state of health by medical professional

A

Disease

36
Q

Proportion of illness in a population

A

Morbidity

37
Q

Incidence of death in a population

A

Mortality

38
Q

Very dynamic, complex & challenging
Multinational companies dominate the industry

A

Phil phamaceutical market

39
Q

Women tend to live longer than men by

A

5 years

40
Q

Morbidity
10 leading causes

A

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

41
Q

Mortality
10 leading Causes

A

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

42
Q

Top pharma company in ph

A

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

43
Q

Most important development in the pharma industry

A

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

44
Q

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

A

Goal of PNDP

45
Q

4 pillars of PNDP

A

Quality assurance
Rational drug use
Self reliance
Tailored procurement

46
Q

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

A

RA 6675
Generics Act of 1988
Sept 13, 1988

47
Q

Full implementation of generics act

A

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

48
Q

PNDF

A

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

49
Q

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

A

Core List

50
Q

List of alternative drugs other than the drugs form cor list

A

Complimemtary list

51
Q

Essential Medicines List

A

PNDF Volume 1

52
Q

Provided by medical professionals

A

Medical care

53
Q

Patients caring for themselves

A

Self care

54
Q

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

A

Self Medication

Pharmacy (25 decks)

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