Therapeutic Index (Therapeutic Ratio) of a drug?
What is Meant by Narrow Therapeutic Index? Which are the drugs with Narrow Therapeutic Index? Narrow Therapeutic Index brand name drugs and their generic versions.
Therapeutic index of a drug is a comparison of a drug, to asses its safety with respect to toxicity, it is a ratio of a concentration of a drug required to produce toxic effect in 50% population to the concentration of the drug required to produce required therapeutic effect in 50% of the population.
That means is a drug with higher therapeutic index is preferable over a drug having a lower therapeutic index (Narrow Therapeutic Index Drug / Critical-Dose drugs) so that a toxic concentration of a drug is not achieved due to any accidental overdose or due to poor elimination of a drug from the body of an individual with metabolic defects or lack of certain enzymes responsible for metabolism of that drug. There were many adverse events reported earlier due to accidental overdose of such Narrow Therapeutic Index Drug (NTI drugs).
The drugs with narrow therapeutic index which are required to be monitored for therapeutic drug concentration (pharmacodynamic monitoring ) in patients include Dimercaprol, Theophylline, Warfarin and Lithium Carbonate, Digoxin, Colchicine. Also some antibiotics too are monitored to minimize adverse effects are gentamicin, vancomycin, amphotericin B, and polymyxin B.
The monitoring the drugs therapeutic concentration in patient is carried out through a therapeutic drug monitoring protocol.
Following are the classes of drugs which are monitored through therapeutic drug monitoring protocol.
1.Aminoglycoside antibiotics (gentamicin)
2.Antiepileptics (such as carbamazepine, phenytoin and valproic acid)
3.Mood stabilisers, especially lithium citrate
4.Antipsychotics (such as pimozide and clozapine)
Narrow therapeutic index drugs are one of the factor for debates for substitution of banrd name drug with their generic drugs.There are products in which small changes in the dose and/or blood concentration could potentially result in clinically important changes in drug efficacy or safety. Usually, these drugs require frequent adjustments in the dose of the drug and careful patient monitoring irrespective of whether the drug is a brand or generic drug product. These drugs may sometimes be described in FDA approved drug labeling as narrow therapeutic range drugs.
Recently US FDA has asked to halt and remove from market all unapproved drugs containing colchicine due to its Narrow Therapeutic Index that had resulted in several fetal incidences.
Which brand name drugs are not required to be substituted with generic drugs is a matter of subject to requirements of different states requirements as well. In US there are different requirements of different states, but in general it is observed in pharmacists that they do not like to substitute a drugs with lower therapeutic index and a Transplant Drug or Anti-rejection Medications with generic drugs unless it is asked by the physician.
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
=====================================================================================================
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What is Meant by Narrow Therapeutic Index? Which are the drugs with Narrow Therapeutic Index? Narrow Therapeutic Index brand name drugs and their generic versions.
Therapeutic index of a drug is a comparison of a drug, to asses its safety with respect to toxicity, it is a ratio of a concentration of a drug required to produce toxic effect in 50% population to the concentration of the drug required to produce required therapeutic effect in 50% of the population.
That means is a drug with higher therapeutic index is preferable over a drug having a lower therapeutic index (Narrow Therapeutic Index Drug / Critical-Dose drugs) so that a toxic concentration of a drug is not achieved due to any accidental overdose or due to poor elimination of a drug from the body of an individual with metabolic defects or lack of certain enzymes responsible for metabolism of that drug. There were many adverse events reported earlier due to accidental overdose of such Narrow Therapeutic Index Drug (NTI drugs).
The drugs with narrow therapeutic index which are required to be monitored for therapeutic drug concentration (pharmacodynamic monitoring ) in patients include Dimercaprol, Theophylline, Warfarin and Lithium Carbonate, Digoxin, Colchicine. Also some antibiotics too are monitored to minimize adverse effects are gentamicin, vancomycin, amphotericin B, and polymyxin B.
The monitoring the drugs therapeutic concentration in patient is carried out through a therapeutic drug monitoring protocol.
Following are the classes of drugs which are monitored through therapeutic drug monitoring protocol.
1.Aminoglycoside antibiotics (gentamicin)
2.Antiepileptics (such as carbamazepine, phenytoin and valproic acid)
3.Mood stabilisers, especially lithium citrate
4.Antipsychotics (such as pimozide and clozapine)
Narrow therapeutic index drugs are one of the factor for debates for substitution of banrd name drug with their generic drugs.There are products in which small changes in the dose and/or blood concentration could potentially result in clinically important changes in drug efficacy or safety. Usually, these drugs require frequent adjustments in the dose of the drug and careful patient monitoring irrespective of whether the drug is a brand or generic drug product. These drugs may sometimes be described in FDA approved drug labeling as narrow therapeutic range drugs.
Recently US FDA has asked to halt and remove from market all unapproved drugs containing colchicine due to its Narrow Therapeutic Index that had resulted in several fetal incidences.
Which brand name drugs are not required to be substituted with generic drugs is a matter of subject to requirements of different states requirements as well. In US there are different requirements of different states, but in general it is observed in pharmacists that they do not like to substitute a drugs with lower therapeutic index and a Transplant Drug or Anti-rejection Medications with generic drugs unless it is asked by the physician.
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
=====================================================================================================
You may also like following articles
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
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 Definitions.
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 coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling 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 , detailed 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
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
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Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
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