1. Biopharmaceutics
1. Introduction to Biopharmaceutics
a. Absorption of drugs from gastrointestinal tract.
b. Drug Distribution.
c. Drug Elimination.
2. Pharmacokinetics
2. Introduction to Pharmacokinetics.
a. Mathematical model
b. Drug levels in blood.
c. Pharmacokinetic model
d. Compartment models
e. Pharmacokinetic study.
3. One compartment open model.
a. Intravenous Injection (Bolus)
b. Intravenous infusion.
4. Multicompartment models.
a. Two compartment open model.
b. IV bolus, IV infusion and oral administration
5. Multiple – Dosage Regimens.
a. Repititive Intravenous injections – One Compartment Open Model
b. Repititive Extravascular dosing – One Compartment Open model
c. Multiple Dose Regimen – Two Compartment Open Model
6. Nonlinear Pharmacokinetics.
a. Introduction
b. Factors causing Non-linearity.
c. Michaelis-menton method of estimating parameters.
7. Noncompartmental Pharmacokinetics.
a. Statistical Moment Theory.
b. MRT for various compartment models.
c. Physiological Pharmacokinetic model.
8. Bioavailability and Bioequivalence.
a. Introduction.
b. Bioavailability study protocol.
c. Methods of Assessment of Bioavailability


1. Improvement of dissolution characteristics of slightly soluble drugs by some methods.
2. Comparison of dissolution studies of two different marketed products of same drug.
3. Influence of polymorphism on solubility and dissolution.
4. Protein binding studies of a highly protein bound drug and poorly protein bound drug.
5. Extent of plasma-protein binding studies on the same drug (i.e. highly and poorly
protein bound drug) at different concentrations in respect of constant time.
6. Bioavailability studies of some commonly used drugs on animal/human model.
7. Calculation of Ka, Ke, t1/2, Cmax, AUC, AUMC, MRT etc. from blood profile data.
8. Calculation of bioavailability from urinary excretion data for two drugs.
9. Calculation of AUC and bioequivalence from the given data for two drugs.
10. In vitro absorption studies.
11. Bioequivalency studies on the different drugs marketed.(eg) Tetracycline, Sulphamethoxzole,
Trimethoprim, Aspirin etc., on animals and human volunteers.
12. Absorption studies in animal inverted intestine using various drugs.
13. Effect on contact time on the plasma protein binding of drugs.
14. Studying metabolic pathways for different drugs based on elimination kinetics data.
15. Calculation of elimination half-life for different drugs by using urinary elimination data and blood level data.
16. Determination of renal clearance.
a. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi
b. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia.
c. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
d. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health Science Press.
e. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
f. Biopharmaceutics; By Swarbrick
g. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal, Vallabh Prakashan Pitampura, Delhi
h. Cilincal Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
i. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing
Company, Pennsylvania 1989.
j. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised
and expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
k. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James, C.
Roylan, Marcel Dekker Inc, New York 1996.

Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice and latest news and new drugs developments.
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

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

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


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

Leave a Reply

%d bloggers like this: