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INTRODUCTION TO
BIOPHARMACEUTICS
PA R T: 0 1
CONTENTS
• Biopharmaceutics
• Pharmacokinetics
• Importance of Pharmacokinetics
• Pharmacodynamics
• Relationship of Pharmacokinetics & Pharmacodynamics
• Plasma level time curve
• Definition:
- MEC, MTC, MSC, Onset time, Tmax, Cmax. AUC
BIOPHARMACEUTICS
 Biopharmaceutics is the study of physiochemical properties of
drugs and dosage forms and affect the route of administration on
the rate and extent of drug absorption.
 Biopharmaceutics is based on the physical and chemical properties
of drug substance and formulation and physiology of the route of
administration.
PHARMACOKINETICS
 Pharmacokinetics is the science of the kinetics of drug absorption
distribution metabolism and excretion.
 The purpose of pharmacokinetic is to study the time course of
amount and concentration of drug and its metabolite in the different
tissue in the body and to construct suitable model to interpret the
data.
IMPORTANCE OF
PHARMACOKINETICS
 Estimation of ADME of drug in the body.
 Estimation of bioavailability of drug from multi - source product.
 Estimation of bioavailability of drug from different formulation of the same drug.
 Optimizing dosage regimen of drugs.
 Calculation of appropriate doses regimen for individuals.
 Determining the effect of plasma protein binding of the drug.
 Determining the effect of food on the absorption of drugs.
 Designing optimal dosage regimen in individual patient.
 Estimation of renal impairment on accumulation and elimination of the drug.
 Calculation of various pharmacokinetic parameters of the drug in order to describe the time
course of drug in the body.
PHARMACODYNAMICS
- Pharmacodynamics is defined as the study of biochemical and physiological
effect of drugs and their mechanism of action.
- It deals with the relationship between concentration of the drug at the site of
action and the magnitude of effect produced by the drug that is the intensity
and time course of effect produced by the drug.
RELATIONSHIP OF
PHARMACOKINETICS &
PHARMACODYNAMICS
Pharmacokinetics Pharmacodynamics
- Dosing and medication errors. - Drug receptor status
- Absorption - Genetic factors
- Tissue and body fluid - Drug interactions
- Mass and volume - Tolerance
- Drug interactions
- Elimination
- Drug metabolism
Prescribed
dosing regimen
Drug at site of
action
Drug effect
PLASMA LEVEL TIME CURVE
 The plasma level time curve is generated
by obtaining the drug concentration in
plasma samples taken as various time
intervals after a drug product is
administered.
 Drug concentration each plasma sample
is plotted against the corresponding time
at which the plasma sample was
withdrawn.
• MSC: maximum safe concentration of drug above which shows toxic effect.
• MEC: minimum concentration of drug needed at the receptor side to produce the diesel
pharmacologic effect.
• MTC: minimum drug concentration needed to just barely produce a toxic effect.
• Onset time: the time required for the drug to reach the MEC. Duration of action: the difference
between onset time and the time for the drug to decline back to the MEC.
• Tmax: the time at which maximum drug concentration observed in plasma. It is proportional
to the rate of drug absorption.
• Cmax: the maximum drug concentration observed in plasma at a particular time. It is usually
related to the dose and rate constant for absorption and elimination of the drug.
• AUC: it is related to the amount of drug absorbed systemically.
…….T0 BE CONTINUED…..
.....Part 2 will be published at 01/04/2021…..

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Introduction to biopharmaceutics (Part:01)

  • 2. CONTENTS • Biopharmaceutics • Pharmacokinetics • Importance of Pharmacokinetics • Pharmacodynamics • Relationship of Pharmacokinetics & Pharmacodynamics • Plasma level time curve • Definition: - MEC, MTC, MSC, Onset time, Tmax, Cmax. AUC
  • 3. BIOPHARMACEUTICS  Biopharmaceutics is the study of physiochemical properties of drugs and dosage forms and affect the route of administration on the rate and extent of drug absorption.  Biopharmaceutics is based on the physical and chemical properties of drug substance and formulation and physiology of the route of administration.
  • 4. PHARMACOKINETICS  Pharmacokinetics is the science of the kinetics of drug absorption distribution metabolism and excretion.  The purpose of pharmacokinetic is to study the time course of amount and concentration of drug and its metabolite in the different tissue in the body and to construct suitable model to interpret the data.
  • 5. IMPORTANCE OF PHARMACOKINETICS  Estimation of ADME of drug in the body.  Estimation of bioavailability of drug from multi - source product.  Estimation of bioavailability of drug from different formulation of the same drug.  Optimizing dosage regimen of drugs.  Calculation of appropriate doses regimen for individuals.  Determining the effect of plasma protein binding of the drug.  Determining the effect of food on the absorption of drugs.  Designing optimal dosage regimen in individual patient.  Estimation of renal impairment on accumulation and elimination of the drug.  Calculation of various pharmacokinetic parameters of the drug in order to describe the time course of drug in the body.
  • 6. PHARMACODYNAMICS - Pharmacodynamics is defined as the study of biochemical and physiological effect of drugs and their mechanism of action. - It deals with the relationship between concentration of the drug at the site of action and the magnitude of effect produced by the drug that is the intensity and time course of effect produced by the drug.
  • 7. RELATIONSHIP OF PHARMACOKINETICS & PHARMACODYNAMICS Pharmacokinetics Pharmacodynamics - Dosing and medication errors. - Drug receptor status - Absorption - Genetic factors - Tissue and body fluid - Drug interactions - Mass and volume - Tolerance - Drug interactions - Elimination - Drug metabolism Prescribed dosing regimen Drug at site of action Drug effect
  • 8. PLASMA LEVEL TIME CURVE  The plasma level time curve is generated by obtaining the drug concentration in plasma samples taken as various time intervals after a drug product is administered.  Drug concentration each plasma sample is plotted against the corresponding time at which the plasma sample was withdrawn.
  • 9. • MSC: maximum safe concentration of drug above which shows toxic effect. • MEC: minimum concentration of drug needed at the receptor side to produce the diesel pharmacologic effect. • MTC: minimum drug concentration needed to just barely produce a toxic effect. • Onset time: the time required for the drug to reach the MEC. Duration of action: the difference between onset time and the time for the drug to decline back to the MEC. • Tmax: the time at which maximum drug concentration observed in plasma. It is proportional to the rate of drug absorption. • Cmax: the maximum drug concentration observed in plasma at a particular time. It is usually related to the dose and rate constant for absorption and elimination of the drug. • AUC: it is related to the amount of drug absorbed systemically.
  • 10. …….T0 BE CONTINUED….. .....Part 2 will be published at 01/04/2021…..