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Sunday, August 8, 2010

CLINICAL PHARMACOKINETICS AND PHARMACOTHERAPEUTIC DRUG MONITORING,PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS

CLINICAL PHARMACOKINETICS AND PHARMACOTHERAPEUTIC DRUG MONITORING,PHARMCY SUBJECTS,THEIR TOPICS AND TEXT BOOKS AND REFERANCE BOOKS
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CLINICAL PHARMACOKINETICS AND PHARMACOTHERAPEUTIC
DRUG MONITORING

1. Introduction to Clinical pharmacokinetics.
2. Design of dosage regimens:
Nomograms and Tabulations in designing dosage regimen, Conversion from intravenous to oral dosing, Determination of dose and dosing intervals, Drug dosing in the elderly and pediatrics and obese patients.
3. Pharmacokinetics of Drug Interaction:
a. Pharmacokinetic drug interactions
b. Inhibition and Induction of Drug metabolism
c. Inhibition of Biliary Excretion.
4. Therapeutic Drug monitoring:
a. Introduction
b. Individualization of drug dosage regimen (Variability – Genetic, Age and Weight , disease,Interacting drugs).
c. Indications for TDM. Protocol for TDM.
d. Pharmacokinetic/Pharmacodynamic Correlation in drug therapy.
e. TDM of drugs used in the following disease conditions: cardiovascular disease, Seizure disorders, Psychiatric conditions, and Organ transplantations.
5. Dosage adjustment in Renal and hepatic Disease.
a. Renal impairment
b. Pharmacokinetic considerations
c. General approach for dosage adjustment in Renal disease.
d. Measurement of Glomerular Filtration rate and creatinine clearance.
e. Dosage adjustment for uremic patients.
f. Extracorporeal removal of drugs.
g. Effect of Hepatic disease on pharmacokinetics.
6. Population Pharmacokinetics.
a. Introduction to Bayesian Theory.
b. Adaptive method or Dosing with feed back.
c. Analysis of Population pharmacokinetic Data.
7. Pharmacogenetics
a. Genetic polymorphism in Drug metabolism: Cytochrome P-450 Isoenzymes.
b. Genetic Polymorphism in Drug Transport and Drug Targets.
c. Pharmacogenetics and Pharmacokinetics/Pharmacodynamic considerations

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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 resitance and Antibiotic resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?


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

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

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 , 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

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
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

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