Pharma Industry Perspectives Flashcards
Pharma manufaturing laboratory
- Research
- Production
- Quality control
- Ditribution or Marketing
Creation of new drugs for new products
Research
May be intentionally or accidentally produced from natural sources or by chemical synthesis
New Drugs
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
Pharmacist in research
1- lead compound selection
Identifying a promising compound
2- discovery testing
Compound design and testing
3- pre clinical research
Safety testing in lab animals
3- manufacture research
Technical development
4- investigational new drug (IND) application
Assessing safety of testing in humans
5- clinical trials
Phase I, phase II, phase III
Safety and efficacy testing
6- new drug application
(NDA)
Assessing the safety and efficacy for marketing
7- postarketing surveilance
Safety and efficacy in general population
Pharmacovigilance
Phase 0
Exploratory, to establish if agent will work as desired
Phase 1
Determine basic pharmacological and toxocological info in humans especially on safety
Phase 2
Conducted on a larger number of patients to further evaluate the safety of the treatment and to determine how well it works
Phase 3
Involves a large number of patients to assess the risks and benefits
Phase 4
Post marketing study to determine if drug works over time and if it works for the purpose other than what it was intended for
Preclinical
3.5 - 6.5 years
Laboratory and animals studies
Assess safety and biological activity
5,000 compounds evaluated
File IND with FDA
In between preclinical and phase 1
Phase 1
1 - 1.5 years
20 - 80 healthy volunteers
Determine the safety and dosage
Phase 2
2 years
100 - 300 patient volunteers
Evaluate effectiveness, look for side effects
5 enter clinical trials
Phase 3
3 - 3.5 years
1,000 - 3,000 patient volunteers
Confirm effectiveness, monitor adverse reactions for long term use
File NDA with the FDA
After phase 3
Inside FDA
1.5 - 2.5 years
Review, process, approval
1 approved
Phase 4
Additional post-marketing testing
Drug development process
15 years
Products sold under a brand name by owner of patent
Patented drug products
Raw materials to finished products
Production
Link between research and production
Pilot plant
Raw materials, the intermediate, and finished products are subjected to qualitative/quantitative check for control purposes
Quality control
Detailmen
Personally contacting potential prescribers, pharmacists regarding their company’s products
Distribution/Marketing
Maintenance or improvement of health
Via prevention, diagnosis, treatment
Healthcare
State of complete physical, mental and social well being and not merely the absence of disease or infirmity
Health
Person’s perception of how he/she feels
Illness
Judgement of one’s state of health by medical professional
Disease
Proportion of illness in a population
Morbidity
Incidence of death in a population
Mortality
Very dynamic, complex & challenging
Multinational companies dominate the industry
Phil phamaceutical market
Women tend to live longer than men by
5 years
Morbidity
10 leading causes
TB
Dengue fever
TB respiratory
Acute watery diarrhea
Influenza
UTI
Bronchitis
Hypertension
ALRTI & Pneumonia
Acute respiratory infection
Mortality
10 leading Causes
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
Top pharma company in ph
Unilab
Pfizer
Abbot laboratories
Glaxosmithkline
Boeringer ingelheim
Sanofi aventis
Novartis
Roche
Merck sharo and dohme
Bayer
Most important development in the pharma industry
Formulation of PNDP(DRUG POLICY)
Signing into law Generic Drug Act of 1988 now known as RA 6675
Make essential drugs available, accessible, and affordable to the people
Goal of PNDP
4 pillars of PNDP
Quality assurance
Rational drug use
Self reliance
Tailored procurement
An act to promote, require, and ensure the production of an adequate supply, distribution, use and acceptance of drugs/medicines by their generic names
RA 6675
Generics Act of 1988
Sept 13, 1988
Full implementation of generics act
Generic labeling
Generic advertising
Generic prescribing
Generic prescribing for single active ingredient, subsequently for multiple active ingredient products
PNDF
Essential Drugs List or National Drug Formulary
A list of drugs prepared & periodically updated by DOH
List of drugs that meets the health care needs of the majority of the population
Core List
List of alternative drugs other than the drugs form cor list
Complimemtary list
Essential Medicines List
PNDF Volume 1
Provided by medical professionals
Medical care
Patients caring for themselves
Self care
Precludes quidance from medical proffesionals
Places an increased responsibility on pharmacists to analyze patients condition
Self Medication
