BPH-407: PHARMACEUTICS-XII
(BIOPHARMACEUTICS AND PHARMACOKINETICS)
THEORY
Max. Marks: 80 Total Hours: 50 (2hrs/week)
Note: Examiner to set eight questions and the candidates are required to attempt any five.
1. Introduction to Biopharmaceutics and Pharmacokinetics and their role in formulation development and clinical setting. (3)
2. Biopharmaceutics: (7)
a. Passage of drug across biological barrier (passive diffusion, active transport, facilitated diffusion and pinocytosis).
b. Factors influencing absorption-physiochemical, physiological and pharmaceutical.
c. Drug distribution in the body, plasma protein binding.
3. Pharmacokinetics: (30)
i. Significance of plasma drug concentration measurement.
ii. Compartmental model: definition and scope.
iii. Pharmacokinetics of drug absorption-zero order and first order absorption rate constant using Wagner-Nelson and Loo-Riegelman method.
iv. Volume of distribution and distribution coefficient.
v. Compartmental kinetics-one compartment and two compartment models. Determination of pharmacokinetics parameters from plasma and urine data after drug administration by intravascular and oral route.
vi. Curve fitting (method of residuals), regression procedures.
vii. Clearance concept, mechanism of renal clearance, clearance ratio, determination of renal clearance.
viii. Hepatic elimination of drugs, first pass effect, extraction ratio, hepatic clearance, billiary excretion, enterohepatic circulation.
ix. Non-linear pharmacokinetics with special reference to one compartment model after I.V. drug administration, Michaels Menten equation, determination of non-linearity (saturation mechanism).
4. Clinical pharmacokinetics: (5)
a. Definition and scope.
b. Dosage adjustment in patients with and without renal and hepatic failure.
c. Dosage regimen adjustment for repeated therapy.
d. Introduction to Pharmacokinetics drug interactions and its significance in combination therapy.
5. Bioavailability and bioequivalence: (5)
a. Measures of bioavailability, Cmax, tmax and Area Under Curve (AUC).
b. Design of single dose bio-equivalence study and relevant statistics.
c. Overview of regulatory requirements for conduction of bio-equivalence study.
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