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Thursday, June 12, 2008
Understanding the Pharama Domain - 1
Before understanding the Domain we should know what are the components of a tablet/syrup/injection which you take. The composition is generally written backside of the tablet. It contains all the chemical names and its compositions.The main components are 1.API's -- Active pharma Ingredients : These are the chemicals/molecules which help in curing the disease 2.Stablizers : These are the components which helps other components not react with each other. 3.Lubricants : These prevent the tablet from sticking to manufacting unit or machine. 4.Excipients : These are non active chemicals which are used for carrying API's 5.Flavors: These are to add taste to the tablet or these are the cosmetic things to please the patients.
Pharama companies are of 2 types
1.Bulk Drug Companies : These are the companies which only produce API's 2.Formulation Companies: These are the companies which make the tablets,syrups etc
Dosage Forms
1.Tablet 2.Injection 3.Capsules 4.Syrup 5.Inhalers(aerosols) 6.Gel forms(Ontiments)
Every country has their own regulatory authories and their own rules which are to be satisfied before they release a drug in their countries
US Regulatory:
FDA - Food and drug administration : Regulatory body which verifies and certifies a drug before it gets relesed in US markets
CDER -- Centre for drug Evaluation and Research CBER -- Centre for Biological evaluation and research
Indian Regulatory
DCGI -- Drug control general of India ,nirman bhavan ,delhi
What are endimics and apedimic diseases?
Apedimic : Spreads every where
endimic : Spreads based on some special resaons like ethics,geography etc
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