BP602TSemester 63 creditsTheory
Biopharmaceutics and Pharmacokinetics
Complete unit-wise syllabus for BP602T as per the PCI B.Pharm NEP 2020 curriculum (Semester 6 — AI in Pharma + Analysis + Internship II).
URL:
https://pharmacode.vercel.app/syllabus/semester-6/bp602t-biopharmaceutics-and-pharmacokinetics/Unit-wise Syllabus
5 Units1
Biopharmaceutics9 Hours- Biopharmaceutics: definition, scope; GI absorption factors — physicochemical (pKa, solubility, lipophilicity, particle size) and physiological (GI motility, pH, blood flow, food effect)
- Biopharmaceutical Classification System (BCS): Class I-IV; BDDCS; regulatory applications of BCS — biowaivers
- Absorption models: first-order, zero-order; lag time; flip-flop kinetics; absorption from various routes (oral, IM, SC, transdermal, pulmonary)
2
Pharmacokinetic Models9 Hours- One-compartment model: IV bolus, IV infusion, oral administration; equations for Cp, AUC, Cmax, tmax, t1/2; calculation examples
- Two-compartment model: IV bolus; α and β phases; distribution phase; elimination phase; equations for each phase; parameter estimation
- Non-compartmental analysis: statistical moment theory; AUC, AUMC, MRT, MAT; advantages over compartmental analysis
3
Pharmacokinetic Parameters and Calculations9 Hours- Clearance: hepatic clearance (extraction ratio), renal clearance, total body clearance; organ clearance models (well-stirred, parallel tube, dispersion model)
- Volume of distribution (Vd): apparent Vd; factors affecting Vd; Vdss vs. Vdβ; clinical implications of Vd changes
- AUC calculation: linear trapezoidal, log-trapezoidal methods; bioavailability calculation; plasma protein binding and its effects on PK parameters
4
Bioavailability and Bioequivalence9 Hours- Bioavailability: absolute and relative bioavailability; factors affecting oral bioavailability; first-pass effect; food-drug interactions affecting bioavailability
- Bioequivalence: definition, types; BE study design (crossover design); acceptance criteria (90% CI within 80-125%); regulatory requirements (USFDA, EMA, CDSCO)
- In vitro-in vivo correlation (IVIVC): levels A, B, C; development and validation; regulatory applications; predictive models for dissolution
5
Population PK, TDM and Special Populations9 Hours- Population pharmacokinetics: NONMEM approach; mixed-effects models; covariate analysis; applications in drug development and clinical practice
- Therapeutic drug monitoring (TDM): drugs with narrow therapeutic index (aminoglycosides, vancomycin, digoxin, lithium, phenytoin, cyclosporine); sampling time optimization; Bayesian forecasting
- Dosage adjustment in special populations: renal impairment (GFR-based dose adjustment), hepatic impairment, paediatrics (allometric scaling), geriatrics, obesity
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What's coming next on this page
- Reference textbooks and recommended reading list
- Previous year question papers (PYQ)
- Topic-wise short notes and revision summaries
- Suggested external resources and video tutorials
Other subjects in Semester 6
BP601TAdvanced PharmacognosyBP603TIntellectual Property RightsBP604TAI Applications in Pharmaceutical SciencesBP605TPharmaceutical AnalysisBP606TPharmaceutical JurisprudenceBP607T AECAEC Elective (Green Chemistry / Materiovigilance / Scientific Writing / Drug Store Management / Medicinal Plant Cultivation / API Sciences)BP608PBiopharmaceutics and Pharmacokinetics (Practical)BP609PPharmaceutical Analysis (Practical)BP610P SECSEC Elective — CADD / Analytical Method Development / Preclinical Studies (Practical)BP611P VACVAC Elective — Professional Skills / PAT & QbD (Practical)BP612IInternship II (Mandatory)