Thursday, June 3, 2010
What is a Generic Drug or Generic Pharmaceutical Products how generic drug is defined
Pharmaceutical or Drug is considered as a generic drug , where it is not protected by patent protection .It is possible that a generic drug have a patent on the formulation but not on the active ingredient, in such case formulation can not be taken by any one but the active ingredient can be formulated so as to form a suitable dosage form.
A generic Drug or Pharmaceutical should contain the same active ingredients as that of the original or parent formulation.
According to the U.S. Food and Drug Administration (FDA),Generic Pharmaceuticals or generic drugs are identical to or acceptable within an bioequivalent range with respect to pharmacokinetic and pharmacodynamic properties of the to the branded pharmaceutical product. Hence, Generic Pharmaceuticals or generic drugs are considered by US FDA as drugs identical in dose, strength, route of administration, safety, efficacy, and intended use.
US FDA establishes required standards for a generic drug giving a range of acceptable values and range of variations that a generic drug is required to be bioequivalent to a brand name drug .
Generic drugs is likely to differ from original brand name drug with respect to inactive ingredients or excipients, its configuration, release mechanisms, packaging shape , scoring.
In the US, drug patents grant twenty years of protection.
Here is the latest news about two pharmaceutical giant companies dispute on patent and generic drug ,
Pfizer sued Teva Pharmaceutical
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coeeficient of a disinfectant
Sterility testing
Cleen Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Controling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Eletronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Latest Pharma Update
USFDA approves first drug Inmazeb to treat Ebola Virus Infection
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Pharmaceutical Manufacturing Guidelines
Reverse Osmosis Membrane Technology RO Water Purification system
SOP for Mechanical Qualification of Dissolution Apparatus
Standard Operating Procedure How to write a SOP
Sterile dosage form manufacturing facility inspection
Sterility testing in sterile dosage form
Sterility testing of Pharmaceuticals dosage forms
Transdermal Drug Delivery System
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Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
What is a Biosimilar or Interchangeable Biopharmaceutical
What is clinical trial protocol
Common Technical Document(CTD)
What is drug receptors?How drug resistance occur
First pass metabolism of a drug
Lyophilization Freeze Drying advantages and disadvantages of lyophilization
What is a prion, What is Mad Cow Disease
What is protein binding of drug, Why a drug is bound to protein
What is protein binding of drug, Why a drug is bound to protein
Requirements Transdermal drug delivery system
Ophthalmic Preparation |Ophthalmic solution and suspensions
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
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