PHARMACEUTICS-V (BIOPHARMACEUTICS &
PHARAMCOKINETICS) (Theory)
Paper 4 Marks 100
1.
DEFINITIONS AND TERMINOLOGY: Biopharmaceutics, Generic Equivalence,
Therapeutic Equivalents, Bioavailability, Bioequivalence, Drug Disposition,
Pharmacokinetics (LADMER: Libration, absorption, distribution, metabolism,
elimination and response).
2.
GASTRO-INTESTINAL ABSORPTION: Forces which help in transmembrane
movements, Anatomical and physiological factors influencing absorption of
drugs. Physicochemical properties of drugs affecting absorption. Absorption of
different oral dosage forms.
3.
BIOLOGICAL HALF LIFE AND VOLUME
OF DISTRIBUTION: Introduction, types, methods
of determination and application.
4.
DRUG CLEARANCE: Introduction, Mechanism, Models,
determination and relationship of clearance with half-life.
5.
PHARMACOKINETICS: Introduction, Linear and Non-linear
Pharmacokinetics. Application of pharmacokinetics in clinical situations.
6.
BIOAVAILABILITY AND
BIOEQUIVALENCE:
a. Introduction.
b. Bioavailability types, parameters, significance and study protocol.
c. Methods of Assessment of Bioavailability
d. Bioequivalence study designs, components and application, report
format
7.
CONCEPT OF COMPARTMENT(S) MODELS:
I.
One compartment open model
a.
Intravenous Injection (Bolus)
b.
Intravenous infusion
II.
Multicompartment models
a.
Two compartment open model
b.
IV bolus, IV infusion and oral
administration
III. Non-compartmental Model
a.
Statistical Moment Theory
b.
MRT for various compartment
models
c.
Physiological Pharmacokinetic
model
8.
MULTIPLE DOSAGE REGIMENS:
a. Introduction: principles of superposition
b. Factors: persistent, accumulation and loss factors
c. Repetitive Intravenous injections-One Compartment Open Model
d. Repetitive Extravascular dosing-One Compartment Open model
e. Multiple Dose Regimen-Two Compartment Open Model
9.
ELIMINATION OF DRUGS:
d)
Hepatic Elimination: Percent of Drug
Metabolized, Drug Biotransformation reactions, (Phase-I reactions and phase-II
reactions), First pass effect, Hepatic clearance of protein bound drugs and
Biliary excretion of drugs.
e)
Renal Excretion of Drugs: Renal
clearance, Tubular Secretion and Tubular Reabsorption.
f)
Elimination of Drugs through other organs: Pulmonary excretion, salivary excretion, Mammilary excretion, Skin
excretion and Genital excretion.
10. PROTEIN BINDING: Introduction, types, kinetics, determination and clinical significance
of drug-protein binding.
11. PHARMACOKINETICS VARIATIONS
IN DISEASE STATES: Determination of
pharmacokinetics variations in renal and hepatic diseases, general approaches
for dose adjustment in renal disease and hepatic diseases.
12. PHARMACOKINETICS OF INTRAVENOUS INFUSIONS:
13. BIOPHARMACEUTICAL ASPECTS IN DEVELOPING A DOSAGE FORM: Drug considerations, drug product
considerations, patient considerations, manufacturing considerations,
pharmacodynamic considerations pharmacokinetic considerations.
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