**LONG ESSAYS 10 marks**

- What are the assumptions made in developing pH partition hypothesis? What are the limitations of pH

partition hypothesis? - Explain different pharmacokinetic models. What are the important points to be considered in developing

equation for a two compartment model? - Explain different methods to enhance the dissolution of poorly soluble drugs.
- Describe the various physiological barriers affecting distribution of drug.
- Describe the various methods of assessment of bioavailability.
- Discuss the one compartment open model for IV bolus administration.
- Write a note on absorption and various mechanisms of drug absorption.
- Define bioavailability, classify bioavailability, and write about bioequivalence study protocol.
- Write about physicochemical and pharmaceutical factors effecting drug absorption.
- Discuss biological and physicochemical factors influencing drug absorption.
- Define bioavailability. Explain any two methods for measurement of bioavailability.
- Define compartment. Discuss method of residuals/feathering method for deriving pharmacocokinetic

parameters following one compartment model. - Define Biopharmaceutics. Discuss in detail kinetics of protein binding.
- Discuss in detail drug metabolism and metabolic pathways of renal excretion.
- Define pharmacokinetics. Derive pharmacokinetic parameters of drug administered by intravenous

injection (bolus). - Classify factors influencing absorption drugs. Explain physicochemical factors in detail.
- Define bioavailability. Write its objectives. Explain different methods for measurement of

bioavailability. - Derive various pharmacokinetic parameters for intravenous infusion by two compartment model.
- Define drug absorption. Explain various mechanisms of drug absorption through GIT.
- Define bioavailability. Discuss the different methods for measurement of bioavailability.
- Explain determination of pharmacokinetic parameters from plasma concentration data after

administration of drug by I.V. infusion. - List the various processes through which drugs can cross the biological membrane. Describe absorption

of drugs from non per oral extra-vascular routes. - Explain various methods to enhance the dissolution rate of poorly soluble drugs.
- Explain determination of pharmacokinetic parameters from plasma concentration data after

administration of drug I.V.bolus. - Discuss in detail the various physiological factors affecting drug absorption.
- Define metabolism. Explain phase I reactions.
- Discuss in detail one-compartment open model for a drug administered as I.V. Bolus. Give the

schematic representation, graphs and equations for the same. - Define drug distribution. Describe the various factors affecting drug distribution.
- Define bioavailability. Explain pharmacokinetic methods for assessment of bioavailability.
- Discuss in detail one-compartment open model for a drug administered as I.V. infusion. Give the

schematic representation, graphs and equations for the same.**SHORT ESSAYS****5 marks** - What do you mean by the term clearance and how will you determine renal clearance.
- Write the advantages and limitation of multiple dose study
- Explain various methods to determine Michaelis-Menten rate constant.
- Discuss about criteria for obtaining a valid urine excretion data.
- Derive an equation to determine concentration of drug given by i.v bolus route following 1 CBM

kinetic. - Explain the role of plasma proteins in drug distribution
- What is a compartment model? Discuss the various types of compartment models.
- Explain apparent volume of distribution and distribution co-efficient.
- Explain the factors affecting drug distribution.
- Write about pH partition theory and its limitation.
- Explain Wagner –Nelson method along with its advantages and limitations.
- Briefly explain about mechanism of renal clearance.
- Brief note on dosage regimen adjustment in patient with renal failure.
- Describe briefly on absolute and relative bioavailability.
- Enumerate different methods for enhancement of dissolution of poorly soluble drugs.
- Discuss about different pharmacokinetic parameters.
- Enumerate various factors affecting protein binding and explain protein related factors.
- Explain sigma-minus method.
- Write in detail about physiological factors effecting drug absorption.
- Write a note on application of pharmacokinetic models.
- Write any two methods to determine bioavailability.
- Write a note on metabolic pathway of renal excretion of drug.
- Explain term in-vitro in-vivo correlation.
- Enumerate the kinetic of protein –drug binding and represent different plots.
- Explain about pseudo polymorphism and biopharmaceutical classification system.
- Determination of absorption coefficient by back residual method.
- Write a note on mamillary and caternary model.
- Enumerate factors affecting protein drug binding. Explain any two factors.
- Compare and contrast active and passive diffusion of drug absorption.
- Define clearance. Write a note on renal clearance
- Define dissolution. Explain various methods to enhance the dissolution of poorly soluble drugs.
- Write a note on applications of pharmacokinetics in pharmacy.
- Describe non-compartment models.
- Explain drug accumulation during multiple dosing.
- Write a note on Michaelis-Menten equation.
- Estimate Km and Vmax.
- Write a note on non per oral extra vascular routes for drug absorption.
- Explain clinical significance of protein binding.
- Enlist in vitro dissolution models. Explain USP type I apparatus.
- Write a note on IVIVC correlations.
- Write a note on physiological models.
- Significance of compartment modeling.
- Explain two compartment open model.
- Explain factors causing non-linearity.
- Write the objectives and significance of non linear pharmacokinetics.
- Enlist various mechanism of drug absorption. Explain active and passive diffusion.
- Write a note on tissue permeability of drugs.
- Write a note on pathways of renal excretion of drugs.
- Explain bioequivalence studies in brief.
- Define compartment. Write its applications in pharmacokinetic analysis.
- Applications and significance of pharmacokinetics.
- Explain two compartment open model.
- Write a note on factors causing nonlinearity.
- Explain the method to determine nonlinearity.
- Explain the factors affecting protein binding of drugs.
- Write a note on tissue permeability of drugs.
- Define metabolism. Write a note on glucuronidation.
- Write a note on non renal excretion of drugs.
- What are pharmacokinetic models? What is the importance and utility of such models?
- Discuss about the blood level curves of a drug administered by I.V. bolus and oral routes.
- Explain in brief what is multi compartment model?
- Explain about Michaelis – Menten’s equation?
- How do you estimate Km and Vmax after i.v. bolus administration of drug following non-linear kinetics?
- Define biopharmaceutics and discuss its role in formulation development.
- Write in detail about protein binding and its significance.
- Write a note on renal excretion of drugs.
- Explain bioequivalence studies.
- Discuss about the blood level curves of a drug administered by I.V. infusion and oral routes.
- What are pharmacokinetic models? Explain various types with their significance.
- Estimate one compartment model parameters by using the method of residuals.
- Explain about Michaelis – Menten’s equation?
- Write a note on determination of Km and Vmax at steady state concentration.
- Discuss the differences between passive diffusion and active transport of drugs.
- Define volume of administration and give its significance.
- Explain the factors affecting renal excretion of drugs.
- Define bioavailability. Mention the objectives of bioavailability studies.
- Write the importance of Compartment modeling in pharmacokinetic study.
- How do you determine KE using rate of excretion method from urine data.
- Define loading and maintenance dose. Give the formula for the same.
- Explain Michaelis –Menten equation in determining non-linearity.
- Explain the various factors leading to non-linearity.
- Explain in vitro and in vivo methods for determining absorption of drugs.
- Explain kinetics of drug protein binding.
- Discuss the various study designs for performing bioequivalence studies.
- Explain various factors affecting biotransformation of drugs.
- Write the applications of pharmacokinetic models.
- Explain the assumptions of one-compartment open model.
- Give schematic representation of two and three compartment models with brief explanation.
- How do you estimate Km and Vmax.
- Explain the causes of nonlinearity.

**SHORT ANSWERES 2 marks**

- Drug dissolution rate and bioavailability
- Define Solid dispersion.
- Maximum Safe concentration, Minimum effective concentration.
- Loading dose and maintenance dose.
- Difference between biopharmaceutices and pharmacokinetics.
- Why non linear kinetics are called dose dependent kinetics.
- Pharmaceutical equivalence and therapeutic equivalence.
- Flip-flop phenomena and lag time.
- Define T max, Cmax.
- Pharmacodynamic drug interaction.
- USP type-II dissolution testing apparatus.
- Biological half life of a drug.
- What is meant by compartment models.
- Define Extraction ratio.
- Mean residence time.
- Michaelis-Menten equation.
- Bioavailability and Bioequivalence.
- Endocytosis.
- Inclusion complex.
- Curve fitting method.
- Proteins responsible for protein binding.
- Limitation of urine data for calculation of pharmacokinetics.
- Clinical pharmacokinetics and its significance.
- Apparent volume of distribution and its significance.
- Facilitated diffusion.
- Non-linear kinetic.
- Gastric emptying time.
- Tissue permeability of drug.
- ABC transporter.
- Plateau principle.
- Define apparent volume of distribution.
- Write any two clinical significance of protein binding.
- Define bioequivalence and therapeutic equivalence.
- List out non renal routes of drug excretion.
- Define caternary model and write its one application.
- Define Biological half-life.
- Define dosage regimen.
- Enlist factors causing non-linearity.
- Define loading and maintenance dosing.
- Define mixed order kinetics.
- Define absorption and distribution of drugs.
- Enlist physicochemical factors affecting drug absorption.
- Enumerate different methods to enhance dissolution of poorly soluble drugs.
- Objectives of bioavailability.
- Define intravenous infusion.
- Plot plasma concentration vs time profile.
- Define intravenous bolus injection.
- Plot multiple dosage regimens.
- State Michaelis-menten equation.
- Enlist the drugs follows non-linear pharmacokinetics.
- Pore transport in absorption.
- Enlist factors affecting protein binding.
- Enumerate various dissolution models.
- Enlist methods to enhance the dissolution rate of poorly soluble drugs.
- Define physiological model and write its one application.
- Define Biological half-life.
- Significance of loading dose in clinical setting.
- Define steady state in drug level study.
- Define nonlinear-pharmacokinetics.
- Define mixed order kinetics.
- Define biopharmaceutics and drug protein binding.
- How components of gastrointestinal fluid affect absorption of drugs.
- Define absolute and relative bioavailability.
- Enlist non renal routes of drug excretion.
- What factors affect half life of the drugs?
- Define volume of distribution, Write its importance.
- Define loading dose and maintenance dose.
- What is the significance of Km and Vmax?.
- Compare the concept of linear and non linear pharmacokinetics.
- Why is it important to monitor drug levels carefully for dose dependency?
- What is hepatic first pass effect?
- What is the influence of GI pH on drug absorption?
- Enlist objectives of bioavailability studies.
- Define clearance. What is its unit?
- Define Cmax and AUC.
- Define apparent volume of distribution and give the mathematical equation to calculate it.
- Define loading dose and maintenance dose.
- What do you mean by central and peripheral compartment in two compartment model?
- Define dose dependent kinetics.
- Compare the concept of linear and non linear pharmacokinetics.
- What is polymorphism.
- Define protein binding.
- What is clearance? Give the formula for same.
- Give the significance of bio-equivalence.
- What are the limitations of one compartment model.
- Write equation for zero order half life and first order half life.
- Give the schematic representation of two compartment open model-IV bolus.
- Define Biological half-life.
- What is multi compartment model?
- What is Km and Vmax?
- What is Pinocytosis and phagocytosis.
- What is the effect of food on absorption of drugs?
- Define biotransformation.
- Write the formula to calculate hepatic extraction ratio.
- What is zero order reaction?
- Draw the blood level profiles for oral administration.
- Define dosing frequency.
- Enlist different pharmacokinetic parameters.
- Name two parameters used in adjusting dosage regimen.
- Give Michaelis-Menton equation. Explain the terms.

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