RGPV B. PHARMACY PHARMACEUTICS XII (BIOPHARMACEUTICS AND PHARMACOKINETICS) PY-802 SYLLABUS
UNIT-I
Introduction to biopharmaceutics and pharmacokinetics development and their role in drug formulation.Biopharmaceutics
UNIT-II
Definition, passage of drugs across biological barrier, Physiochemical, Biological and Pharmacaceutical factors influencing biopharmaceutical performance of drugs.
1. Gastrointestinal absorption of drugs: Passage of drugs across biological membranes, nature of biological membranes, gastrointestinal absorption mechanisms.
2. Factors affecting drug absorption: Physiological factors, dietary factors, physicochemical factors, pH partition hypothesis, dosage form factors.
3. Methods of studying gastrointestinal absorption: In vitro and in vivo methods.
4. Drug disposition: Distribution in blood, cellular distribution, plasma protein binding, tissue protein binding.Drug Excretion: Routes of drug excretion, renal excretion of drugs, factors affecting renal excretion, biliary and salivary excretionof drugs.
Definition, passage of drugs across biological barrier, Physiochemical, Biological and Pharmacaceutical factors influencing biopharmaceutical performance of drugs.
1. Gastrointestinal absorption of drugs: Passage of drugs across biological membranes, nature of biological membranes, gastrointestinal absorption mechanisms.
2. Factors affecting drug absorption: Physiological factors, dietary factors, physicochemical factors, pH partition hypothesis, dosage form factors.
3. Methods of studying gastrointestinal absorption: In vitro and in vivo methods.
4. Drug disposition: Distribution in blood, cellular distribution, plasma protein binding, tissue protein binding.Drug Excretion: Routes of drug excretion, renal excretion of drugs, factors affecting renal excretion, biliary and salivary excretionof drugs.
UNIT-III
Drug biotransformation : Pathways of drug metabolism, drug metabolizing enzymes, factors affecting drug metabolism and drugresponse, inhibition and stimulation of drug metabolism.
PharmacokineticsAbsorbtion, distribution, metabolism and excretion of drugs, fluid compartment and circulatory system, protien binding,significance of plasma drug concentration measurement.Compartment Models
Drug biotransformation : Pathways of drug metabolism, drug metabolizing enzymes, factors affecting drug metabolism and drugresponse, inhibition and stimulation of drug metabolism.
PharmacokineticsAbsorbtion, distribution, metabolism and excretion of drugs, fluid compartment and circulatory system, protien binding,significance of plasma drug concentration measurement.Compartment Models
UNIT-IV
Model selection criteria, alaika information criterion, one-compartment and two-compartment models, Wagner-Nelson and looRiegelman methods for estimation of absorption constants. Curve fittings, regression procedure and area under blood level curves.
Clinical Pharmacokinetics.Urinary excretions, computation of pharmacokinetic parameters from urine data, haepetic clearance, biliary excretion, excretion ratio, dosage regimen adjustment in patients with and without renal failure, pharmacokinetic drug interactions and theirsignificance in combination therapy.
Model selection criteria, alaika information criterion, one-compartment and two-compartment models, Wagner-Nelson and looRiegelman methods for estimation of absorption constants. Curve fittings, regression procedure and area under blood level curves.
Clinical Pharmacokinetics.Urinary excretions, computation of pharmacokinetic parameters from urine data, haepetic clearance, biliary excretion, excretion ratio, dosage regimen adjustment in patients with and without renal failure, pharmacokinetic drug interactions and theirsignificance in combination therapy.
UNIT-V
Bioavailability and Bioequivalance:Bioavailability and Bio-equivalance, Federal requirements, Methods of determination of bioavailability using blood level and urinary excretion data, design and evaluations, bioavailability assessment.
Bioavailability and Bioequivalance:Bioavailability and Bio-equivalance, Federal requirements, Methods of determination of bioavailability using blood level and urinary excretion data, design and evaluations, bioavailability assessment.
VIII-P-2-PHARMACEUTICS-XII PRACTICALS
(BIOPHARMACEUTICS AND PHARMACOKINETICS)
(BIOPHARMACEUTICS AND PHARMACOKINETICS)
Experiments based on theory.Statistical treatment of pharmaceutical data.
Books recommended
1. Gibaldi, M. and Perrier d, Pharmacokinetics, Marcel Decker, New York.
2. Notari, R.E., Biopharmaceutics and Pharmacokinetics-An Introduction, Marcel Decker, New York.
3. Jaiswal , Brahmankar
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