Bioequivalence studies
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This document discusses bioequivalence and biopharmaceutics. It defines bioequivalence as the same rate and extent of absorption of the active ingredients in two drug products. Bioequivalence studies compare generic drugs to ensure they are biologically equivalent to the branded drug. In vivo and in vitro bioequivalence studies are described, with in vivo requiring human subjects and in vitro using dissolution testing. Factors that can impact bioequivalence like solubility, excipients, and absorption site are outlined.
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Bioequivalence Studies
Bioequivalence studies for various drug molecules formulated in the market is outlined in this presentation.
Bioequivalence studies
The document discusses bioequivalence, which refers to two drug products having the same rate and extent of absorption. There are two types of bioequivalence testing: in vivo, which involves human subjects; and in vitro, which involves dissolution testing. In vivo testing is generally required for immediate-release oral drugs that are systemically absorbed, have a narrow therapeutic index, or have complicated absorption properties. In vitro dissolution testing may suffice in some cases, such as when only the drug strength differs between products or when an acceptable in vitro-in vivo correlation exists.
IN VITRO - IN VIVO CORRELATION
United State Pharmacopoeia (USP) The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definition IVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Bioavailability & Bioequivalence Studies
This presentation summarizes key concepts regarding bioavailability and bioequivalence studies. It defines bioavailability as a measure of the rate and amount of drug reaching systemic circulation following administration of a dosage form. Absolute bioavailability compares intravenous and oral administration, while relative bioavailability compares oral formulations. The objectives of these studies are outlined. Methods of measuring bioavailability through pharmacokinetic methods like plasma level time studies and urinary excretion studies are described. Bioequivalence ensures two dosage forms reach systemic circulation at the same rate and extent. Study designs for in vivo and in vitro bioequivalence experiments are discussed, including completely randomized, randomized block, repeated measures, cross-over, and Latin square designs.
Causes of Non linear pharmacokinetics
Nonlinear pharmacokinetics can occur when the rate processes of drug absorption, distribution, metabolism, or excretion become dependent on dose size due to saturation of carrier proteins or enzymes. Some specific causes of nonlinearity include saturation of transporters during drug absorption, saturation of plasma protein binding sites or tissue binding sites during distribution, capacity-limited drug metabolism by enzyme saturation, and saturation of active tubular secretion or reabsorption processes during excretion. The Michaelis-Menten equation can describe the kinetics of these saturable, capacity-limited processes.
Bioequivalence 112070804009
This document provides an introduction to bioequivalence studies, including definitions of key terms, the need for and importance of bioequivalence studies, criteria for establishing a bioequivalence requirement, types of bioequivalence studies, design of bioequivalence studies, evaluation of bioequivalence study results, and clinical significance. It discusses in vivo and in vitro bioequivalence study types and designs, including factors such as single dose, multiple dose, fasting, food effect, and crossover designs. Statistical evaluation methods including ANOVA, confidence intervals, and bioequivalence limits of 80-125% are also summarized.
P h partition hypothesis
The document discusses the pH partition hypothesis, which states that the absorption of drugs across biomembranes is governed by the drug's dissociation constant (pKa), lipid solubility of the un-ionized form, and the pH of the absorption site. According to the hypothesis, only the un-ionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its un-ionized form can be calculated using the Henderson-Hasselbach equation based on the drug's pKa and the pH. However, the pH partition theory is an oversimplification and does not always accurately predict drug absorption behavior.
Bioavailability , absolute bioavalability, relative bioavailability, Purpose ...
Bioavailability , absolute bioavalability, relative bioavailability, Purpose ...Manikant Prasad Shah
1) Bioavailability studies assess the rate and extent of drug absorption from dosage forms. They are important for developing new drug products and formulations to determine therapeutic effectiveness.
2) There are two types of bioavailability - absolute compares drug absorption from a non-IV route to IV, relative compares absorption between formulations.
3) Methods to assess bioavailability include pharmacokinetic methods like plasma concentration-time profiles and urinary excretion studies, and pharmacodynamic methods like measuring pharmacological or therapeutic responses.Recommended
Bioequivalence Studies
Bioequivalence studies for various drug molecules formulated in the market is outlined in this presentation.
Bioequivalence studies
The document discusses bioequivalence, which refers to two drug products having the same rate and extent of absorption. There are two types of bioequivalence testing: in vivo, which involves human subjects; and in vitro, which involves dissolution testing. In vivo testing is generally required for immediate-release oral drugs that are systemically absorbed, have a narrow therapeutic index, or have complicated absorption properties. In vitro dissolution testing may suffice in some cases, such as when only the drug strength differs between products or when an acceptable in vitro-in vivo correlation exists.
IN VITRO - IN VIVO CORRELATION
United State Pharmacopoeia (USP) The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definition IVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Bioavailability & Bioequivalence Studies
This presentation summarizes key concepts regarding bioavailability and bioequivalence studies. It defines bioavailability as a measure of the rate and amount of drug reaching systemic circulation following administration of a dosage form. Absolute bioavailability compares intravenous and oral administration, while relative bioavailability compares oral formulations. The objectives of these studies are outlined. Methods of measuring bioavailability through pharmacokinetic methods like plasma level time studies and urinary excretion studies are described. Bioequivalence ensures two dosage forms reach systemic circulation at the same rate and extent. Study designs for in vivo and in vitro bioequivalence experiments are discussed, including completely randomized, randomized block, repeated measures, cross-over, and Latin square designs.
Causes of Non linear pharmacokinetics
Nonlinear pharmacokinetics can occur when the rate processes of drug absorption, distribution, metabolism, or excretion become dependent on dose size due to saturation of carrier proteins or enzymes. Some specific causes of nonlinearity include saturation of transporters during drug absorption, saturation of plasma protein binding sites or tissue binding sites during distribution, capacity-limited drug metabolism by enzyme saturation, and saturation of active tubular secretion or reabsorption processes during excretion. The Michaelis-Menten equation can describe the kinetics of these saturable, capacity-limited processes.
Bioequivalence 112070804009
This document provides an introduction to bioequivalence studies, including definitions of key terms, the need for and importance of bioequivalence studies, criteria for establishing a bioequivalence requirement, types of bioequivalence studies, design of bioequivalence studies, evaluation of bioequivalence study results, and clinical significance. It discusses in vivo and in vitro bioequivalence study types and designs, including factors such as single dose, multiple dose, fasting, food effect, and crossover designs. Statistical evaluation methods including ANOVA, confidence intervals, and bioequivalence limits of 80-125% are also summarized.
P h partition hypothesis
The document discusses the pH partition hypothesis, which states that the absorption of drugs across biomembranes is governed by the drug's dissociation constant (pKa), lipid solubility of the un-ionized form, and the pH of the absorption site. According to the hypothesis, only the un-ionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its un-ionized form can be calculated using the Henderson-Hasselbach equation based on the drug's pKa and the pH. However, the pH partition theory is an oversimplification and does not always accurately predict drug absorption behavior.
Bioavailability , absolute bioavalability, relative bioavailability, Purpose ...
Bioavailability , absolute bioavalability, relative bioavailability, Purpose ...Manikant Prasad Shah
1) Bioavailability studies assess the rate and extent of drug absorption from dosage forms. They are important for developing new drug products and formulations to determine therapeutic effectiveness.
2) There are two types of bioavailability - absolute compares drug absorption from a non-IV route to IV, relative compares absorption between formulations.
3) Methods to assess bioavailability include pharmacokinetic methods like plasma concentration-time profiles and urinary excretion studies, and pharmacodynamic methods like measuring pharmacological or therapeutic responses.Bio pharmaceutical classification System [BCS]
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
Pharmacokinetic models
This document discusses various approaches used to model pharmacokinetics. It describes compartment models, physiological models, and distributed parameter models that can be used to mathematically describe drug absorption, distribution, metabolism and excretion over time. It also discusses model-independent or non-compartmental analysis, which does not require assumptions about specific compartment models. Compartment models include mammillary and catenary models. Physiological models group tissues into compartments based on similar perfusion properties. Distributed parameter models account for variations in organ blood flow and drug diffusion.
Non linear kinetics
This document discusses linear and nonlinear pharmacokinetics. [1] Linear pharmacokinetics follow first-order kinetics where the rate of drug absorption, distribution, metabolism and excretion is proportional to dose. [2] Nonlinear pharmacokinetics occur when these processes become saturated at high doses due to limited enzyme or transporter capacity. [3] Michaelis-Menten kinetics are often used to model nonlinear processes and estimate parameters like Vmax and Km.
Theories of Dissolution
DISSOLUTION
Dissolution is defined as a process in which a solid substance solubilises in a given solvent.
(i.e. mass transfer from the solid surface to the liquid phase.)
Three Theories:
Diffusion layer model / Film theory
Danckwert’s model / Penetration or Surface renewal theory
Interfacial barrier model / Double barrier or Limited solvation theory
In-Vivo In-Vitro Correlation
This document discusses in vitro-in vivo correlations (IVIVCs). It defines IVIVC as a predictive mathematical model relating an in vitro property (e.g. dissolution rate) to an in vivo response (e.g. absorption rate). The document outlines the significance of IVIVCs in reducing bioequivalence studies and supporting biowaivers. It describes different levels of IVIVC (A, B, C) and parameters that can be correlated (dissolution rate to absorption rate; percent dissolved to percent absorbed). The document provides examples of IVIVC case studies and concludes that current regulatory guidelines only apply to oral dosage forms, while further research is needed to develop IVIVCs for other drug products.
IVIVC
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
Physicochemical Properties effect on Absorption of Drugs
This document discusses factors affecting drug absorption from oral dosage forms. It covers physiological factors like gastric emptying time and pH, as well as physicochemical drug properties including solubility, dissolution rate, and polymorphism that influence drug absorption. Particle size and surface area are emphasized, with smaller particles increasing absorption for hydrophilic drugs but potentially decreasing it for hydrophobic drugs. The pH partition hypothesis and importance of drug stability are also summarized.
Mechanism of drug absorption in git
1. Drug absorption involves the movement of unchanged drug molecules from the site of administration into systemic circulation. It occurs primarily through the gastrointestinal (GI) tract and is influenced by factors like solubility, permeability, and transport mechanisms.
2. There are three main mechanisms of drug transport across the GI tract - transcellular, paracellular, and vesicular. Transcellular transport occurs across cells and includes passive diffusion, active transport, and carrier-mediated transport. Paracellular transport is between cell junctions. Vesicular transport involves endocytosis within cells.
3. The most common mechanism is passive diffusion, which does not require energy. Other mechanisms like active transport and carrier-mediated transport use
pH partition theory of drug absorption
The document discusses the pH partition theory of drug absorption from the gastrointestinal tract. The theory states that a drug's absorption is governed by its dissociation constant (pKa), the lipid solubility of its unionized form, and the pH of the absorption site. According to the theory, only the unionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its unionized form depends on the drug's pKa and the pH of the solution based on the Henderson-Hasselbalch equation. While the pH partition theory explains many observations, it has limitations such as not accounting for the presence of an unstirred water layer and virtual membrane pH at the absorption
Bioavailability and bioequivalence
This document discusses bioavailability and bioequivalence concepts including definitions, objectives of bioavailability studies, types of bioavailability studies, and methods of measuring bioavailability. It also covers bioequivalence experimental study designs including completely randomized, randomized block, repeated measures, and Latin square designs. In vitro dissolution studies and developing in vitro-in vivo correlations to help assess bioavailability without human studies are also summarized.
Pharmacokinetic models
PHARMACOKINETIC MODELS
Drug movement within the body is a complex process. The major objective is therefore to develop a generalized and simple approach to describe, analyse and interpret the data obtained during in vivo drug disposition studies.
The two major approaches in the quantitative study of various kinetic processes of drug disposition in the body are
Model approach, and
Model-independent approach (also called as non-compartmental analysis).
bioavailability & bioequivalence
Bioavailability refers to the amount of drug that enters systemic circulation after administration. It is measured using pharmacokinetic methods like plasma concentration-time profiles and urinary excretion studies, or pharmacodynamic methods like measuring physiological responses. Key parameters include AUC, Cmax, Tmax, which provide information on extent and rate of absorption. Absolute bioavailability compares oral and intravenous dosing, while relative bioavailability compares different oral formulations. Multiple dose studies can assess steady-state characteristics. Bioavailability studies are important for drug development and quality control.
Dissolution
This document discusses dissolution, which is defined as the process by which a solid substance solubilizes in a given solvent. Key points include:
- Drugs are classified into BCS classes based on their solubility and permeability. The four classes are high/high, high/low, low/high, and low/low.
- Noyes-Whitney and Hixson-Crowell equations describe dissolution kinetics under non-sink and sink conditions. Factors like surface area, diffusion coefficient, and concentration gradients impact dissolution rate.
- In vitro dissolution testing uses apparatus like baskets, paddles, and flow-through cells per BP and USP methods to simulate in vivo conditions and assess
Non linear pharmacokinetics
The document discusses nonlinear pharmacokinetics and chronopharmacokinetics. Nonlinear pharmacokinetics occurs when the body's absorption, distribution, metabolism, or excretion of a drug becomes saturated at higher doses. This can cause the rate of drug elimination to decrease. Examples of processes that can become saturated include drug metabolism and renal excretion. Circadian rhythms can also impact drug pharmacokinetics by influencing absorption, distribution, metabolism, and excretion over 24-hour periods. Accounting for these temporal changes can improve drug therapy for circadian phase-dependent diseases.
Methods For Assesment Of Bioavailability
This document summarizes a seminar presentation on methods for determining bioavailability. It defines bioavailability as the rate and extent to which the active substance of a drug is absorbed and available at the site of action. It then describes the main objectives of bioavailability studies which include aiding new drug and formulation development. The key methods discussed for assessing bioavailability include measuring plasma drug concentration, urinary drug excretion, acute pharmacodynamic effects, clinical observations, and in vitro drug dissolution studies. Specific parameters are defined for each method such as Cmax, AUC, tmax, Du, and Emax. Finally, the document summarizes two literature articles that developed formulations to enhance the oral bioavailability of curcumin and edarav
Methods of Assessing Bioavailability
1. Measurement of Bioavailability:
Direct and indirect methods may be used to assess drug bioavailability. The in-vivo bioavailability of a drug product is demonstrated by the rate and extent of drug absorption, as determined by comparison of measured parameters, e.g., concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects.
For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
The design of the bioavailability study depends on the objectives of the study, the ability to analyze the drug (and metabolites) in biological fluids, the pharmacodynamics of the drug substance, the route of drug administration, and the nature of the drug product.
Pharmacokinetic and/or pharmacodynamic parameters as well as clinical observations and in-vitro studies may be used to determine drug bioavailability from a drug product.
1.1. Pharmacokinetic methods:
These are very widely used and based upon the assumption that the pharmacokinetic profile reflects the therapeutic effectiveness of a drug. Thus these are indirect methods. The two major pharmacokinetic methods are:
The major pharmacokinetic methods are:
Plasma / blood level time profile.
o Time for peak plasma (blood) concentration (t max)
o Peak plasma drug concentration (Cmax)
o Area under the plasma drug concentration–time curve (AUC)
Urinary excretion studies.
o Cumulative amount of drug excreted in the urine (Du)
o Rate of drug excretion in the urine (dDu/dt)
o Time for maximum urinary excretion (t)
C. Other biological fluids
1.2. Pharmacodynamic methods:
IT involves direct measurement of drug effect on a (patho) physiological process as a function of time. Disadvantages of it may be high variability, difficult to measure, limited choices, less reliable, more subjective, drug response influenced by several physiological & environmental factors.
They involve determination of bioavailability from:
Acute pharmacological response.
Therapeutic response.
1.3. In-vitro dissolution studies
Closed compartment apparatus
Open compartment apparatus
Dialysis systems.
1.4. Clinical observations
Well-controlled clinical trials
IVIVC
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
Causes of non linearity in pharmacokinetics pdf
It includes the basic concept of linear and non-linear pharmacokinetics and the causes of non linearity in pharmacokinetics.
Methods of enhancing bioavailability of drugs
This document discusses various approaches to enhancing the bioavailability of drugs, including enhancing drug solubility, permeability, stability, and gastrointestinal retention. It describes how bioavailability can be improved by increasing a drug's dissolution rate through methods like micronization, nanosuspensions, and use of surfactants. Permeability can be enhanced using lipid technologies, ion pairing, or penetration enhancers. Stability can be improved with enteric coatings or complexation. Gastrointestinal retention time can be lengthened to boost absorption.
Factors affecting design of Controlled Release Drug Delivery Systems (write-up)
This document discusses factors affecting the design of controlled release drug delivery systems (CRDDS). It outlines several key considerations including selection of the drug candidate based on properties like solubility and half-life. It also discusses medical rationales like dosing frequency and patient compliance. Biological factors that influence absorption, distribution, and elimination are examined. Physicochemical properties of the drug like solubility, molecular size, and ionization must also be considered. The document provides an in-depth overview of factors involved in developing an effective CRDDS formulation.
Bioavailability and bioequivalance
The document discusses bioavailability and bioequivalence studies. It defines bioavailability as the rate and extent of an active drug reaching systemic circulation and being available at its site of action. Bioequivalence refers to comparing the bioavailability of a drug from different formulations. The document outlines the objectives, types of study designs, important considerations like sampling, subjects, and analysis methods for bioavailability and bioequivalence studies.
bioequivalencestudies-130210235231-phpapp02.pptx
The document discusses bioequivalence, which refers to two drug products having the same rate and extent of absorption. Bioequivalence can be assessed through in vivo or in vitro methods. In vivo methods involve pharmacokinetic or pharmacodynamic studies in humans. In vitro methods involve dissolution studies to assess equivalence. The criteria for determining whether in vivo or in vitro studies are needed are described, including factors like dosage form, therapeutic index, and pharmacokinetics of the drug. Biowaivers for in vitro equivalence without in vivo studies are possible under certain specified conditions.
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Bio pharmaceutical classification System [BCS]
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
Pharmacokinetic models
This document discusses various approaches used to model pharmacokinetics. It describes compartment models, physiological models, and distributed parameter models that can be used to mathematically describe drug absorption, distribution, metabolism and excretion over time. It also discusses model-independent or non-compartmental analysis, which does not require assumptions about specific compartment models. Compartment models include mammillary and catenary models. Physiological models group tissues into compartments based on similar perfusion properties. Distributed parameter models account for variations in organ blood flow and drug diffusion.
Non linear kinetics
This document discusses linear and nonlinear pharmacokinetics. [1] Linear pharmacokinetics follow first-order kinetics where the rate of drug absorption, distribution, metabolism and excretion is proportional to dose. [2] Nonlinear pharmacokinetics occur when these processes become saturated at high doses due to limited enzyme or transporter capacity. [3] Michaelis-Menten kinetics are often used to model nonlinear processes and estimate parameters like Vmax and Km.
Theories of Dissolution
DISSOLUTION
Dissolution is defined as a process in which a solid substance solubilises in a given solvent.
(i.e. mass transfer from the solid surface to the liquid phase.)
Three Theories:
Diffusion layer model / Film theory
Danckwert’s model / Penetration or Surface renewal theory
Interfacial barrier model / Double barrier or Limited solvation theory
In-Vivo In-Vitro Correlation
This document discusses in vitro-in vivo correlations (IVIVCs). It defines IVIVC as a predictive mathematical model relating an in vitro property (e.g. dissolution rate) to an in vivo response (e.g. absorption rate). The document outlines the significance of IVIVCs in reducing bioequivalence studies and supporting biowaivers. It describes different levels of IVIVC (A, B, C) and parameters that can be correlated (dissolution rate to absorption rate; percent dissolved to percent absorbed). The document provides examples of IVIVC case studies and concludes that current regulatory guidelines only apply to oral dosage forms, while further research is needed to develop IVIVCs for other drug products.
IVIVC
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
Physicochemical Properties effect on Absorption of Drugs
This document discusses factors affecting drug absorption from oral dosage forms. It covers physiological factors like gastric emptying time and pH, as well as physicochemical drug properties including solubility, dissolution rate, and polymorphism that influence drug absorption. Particle size and surface area are emphasized, with smaller particles increasing absorption for hydrophilic drugs but potentially decreasing it for hydrophobic drugs. The pH partition hypothesis and importance of drug stability are also summarized.
Mechanism of drug absorption in git
1. Drug absorption involves the movement of unchanged drug molecules from the site of administration into systemic circulation. It occurs primarily through the gastrointestinal (GI) tract and is influenced by factors like solubility, permeability, and transport mechanisms.
2. There are three main mechanisms of drug transport across the GI tract - transcellular, paracellular, and vesicular. Transcellular transport occurs across cells and includes passive diffusion, active transport, and carrier-mediated transport. Paracellular transport is between cell junctions. Vesicular transport involves endocytosis within cells.
3. The most common mechanism is passive diffusion, which does not require energy. Other mechanisms like active transport and carrier-mediated transport use
pH partition theory of drug absorption
The document discusses the pH partition theory of drug absorption from the gastrointestinal tract. The theory states that a drug's absorption is governed by its dissociation constant (pKa), the lipid solubility of its unionized form, and the pH of the absorption site. According to the theory, only the unionized form of an acid or base drug can be absorbed if it is sufficiently lipid soluble. The fraction of a drug in its unionized form depends on the drug's pKa and the pH of the solution based on the Henderson-Hasselbalch equation. While the pH partition theory explains many observations, it has limitations such as not accounting for the presence of an unstirred water layer and virtual membrane pH at the absorption
Bioavailability and bioequivalence
This document discusses bioavailability and bioequivalence concepts including definitions, objectives of bioavailability studies, types of bioavailability studies, and methods of measuring bioavailability. It also covers bioequivalence experimental study designs including completely randomized, randomized block, repeated measures, and Latin square designs. In vitro dissolution studies and developing in vitro-in vivo correlations to help assess bioavailability without human studies are also summarized.
Pharmacokinetic models
PHARMACOKINETIC MODELS
Drug movement within the body is a complex process. The major objective is therefore to develop a generalized and simple approach to describe, analyse and interpret the data obtained during in vivo drug disposition studies.
The two major approaches in the quantitative study of various kinetic processes of drug disposition in the body are
Model approach, and
Model-independent approach (also called as non-compartmental analysis).
bioavailability & bioequivalence
Bioavailability refers to the amount of drug that enters systemic circulation after administration. It is measured using pharmacokinetic methods like plasma concentration-time profiles and urinary excretion studies, or pharmacodynamic methods like measuring physiological responses. Key parameters include AUC, Cmax, Tmax, which provide information on extent and rate of absorption. Absolute bioavailability compares oral and intravenous dosing, while relative bioavailability compares different oral formulations. Multiple dose studies can assess steady-state characteristics. Bioavailability studies are important for drug development and quality control.
Dissolution
This document discusses dissolution, which is defined as the process by which a solid substance solubilizes in a given solvent. Key points include:
- Drugs are classified into BCS classes based on their solubility and permeability. The four classes are high/high, high/low, low/high, and low/low.
- Noyes-Whitney and Hixson-Crowell equations describe dissolution kinetics under non-sink and sink conditions. Factors like surface area, diffusion coefficient, and concentration gradients impact dissolution rate.
- In vitro dissolution testing uses apparatus like baskets, paddles, and flow-through cells per BP and USP methods to simulate in vivo conditions and assess
Non linear pharmacokinetics
The document discusses nonlinear pharmacokinetics and chronopharmacokinetics. Nonlinear pharmacokinetics occurs when the body's absorption, distribution, metabolism, or excretion of a drug becomes saturated at higher doses. This can cause the rate of drug elimination to decrease. Examples of processes that can become saturated include drug metabolism and renal excretion. Circadian rhythms can also impact drug pharmacokinetics by influencing absorption, distribution, metabolism, and excretion over 24-hour periods. Accounting for these temporal changes can improve drug therapy for circadian phase-dependent diseases.
Methods For Assesment Of Bioavailability
This document summarizes a seminar presentation on methods for determining bioavailability. It defines bioavailability as the rate and extent to which the active substance of a drug is absorbed and available at the site of action. It then describes the main objectives of bioavailability studies which include aiding new drug and formulation development. The key methods discussed for assessing bioavailability include measuring plasma drug concentration, urinary drug excretion, acute pharmacodynamic effects, clinical observations, and in vitro drug dissolution studies. Specific parameters are defined for each method such as Cmax, AUC, tmax, Du, and Emax. Finally, the document summarizes two literature articles that developed formulations to enhance the oral bioavailability of curcumin and edarav
Methods of Assessing Bioavailability
1. Measurement of Bioavailability:
Direct and indirect methods may be used to assess drug bioavailability. The in-vivo bioavailability of a drug product is demonstrated by the rate and extent of drug absorption, as determined by comparison of measured parameters, e.g., concentration of the active drug ingredient in the blood, cumulative urinary excretion rates, or pharmacological effects.
For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.
The design of the bioavailability study depends on the objectives of the study, the ability to analyze the drug (and metabolites) in biological fluids, the pharmacodynamics of the drug substance, the route of drug administration, and the nature of the drug product.
Pharmacokinetic and/or pharmacodynamic parameters as well as clinical observations and in-vitro studies may be used to determine drug bioavailability from a drug product.
1.1. Pharmacokinetic methods:
These are very widely used and based upon the assumption that the pharmacokinetic profile reflects the therapeutic effectiveness of a drug. Thus these are indirect methods. The two major pharmacokinetic methods are:
The major pharmacokinetic methods are:
Plasma / blood level time profile.
o Time for peak plasma (blood) concentration (t max)
o Peak plasma drug concentration (Cmax)
o Area under the plasma drug concentration–time curve (AUC)
Urinary excretion studies.
o Cumulative amount of drug excreted in the urine (Du)
o Rate of drug excretion in the urine (dDu/dt)
o Time for maximum urinary excretion (t)
C. Other biological fluids
1.2. Pharmacodynamic methods:
IT involves direct measurement of drug effect on a (patho) physiological process as a function of time. Disadvantages of it may be high variability, difficult to measure, limited choices, less reliable, more subjective, drug response influenced by several physiological & environmental factors.
They involve determination of bioavailability from:
Acute pharmacological response.
Therapeutic response.
1.3. In-vitro dissolution studies
Closed compartment apparatus
Open compartment apparatus
Dialysis systems.
1.4. Clinical observations
Well-controlled clinical trials
IVIVC
An in-vitro in-vivo correlation (IVIVC) has been defined by the U.S. Food and Drug Administration (FDA) as "a predictive mathematical model describing the relationship between an in-vitro property of a dosage form and an in-vivo response".
Causes of non linearity in pharmacokinetics pdf
It includes the basic concept of linear and non-linear pharmacokinetics and the causes of non linearity in pharmacokinetics.
Methods of enhancing bioavailability of drugs
This document discusses various approaches to enhancing the bioavailability of drugs, including enhancing drug solubility, permeability, stability, and gastrointestinal retention. It describes how bioavailability can be improved by increasing a drug's dissolution rate through methods like micronization, nanosuspensions, and use of surfactants. Permeability can be enhanced using lipid technologies, ion pairing, or penetration enhancers. Stability can be improved with enteric coatings or complexation. Gastrointestinal retention time can be lengthened to boost absorption.
Factors affecting design of Controlled Release Drug Delivery Systems (write-up)
This document discusses factors affecting the design of controlled release drug delivery systems (CRDDS). It outlines several key considerations including selection of the drug candidate based on properties like solubility and half-life. It also discusses medical rationales like dosing frequency and patient compliance. Biological factors that influence absorption, distribution, and elimination are examined. Physicochemical properties of the drug like solubility, molecular size, and ionization must also be considered. The document provides an in-depth overview of factors involved in developing an effective CRDDS formulation.
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The document discusses bioavailability and bioequivalence studies. It defines bioavailability as the rate and extent of an active drug reaching systemic circulation and being available at its site of action. Bioequivalence refers to comparing the bioavailability of a drug from different formulations. The document outlines the objectives, types of study designs, important considerations like sampling, subjects, and analysis methods for bioavailability and bioequivalence studies.
bioequivalencestudies-130210235231-phpapp02.pptx
The document discusses bioequivalence, which refers to two drug products having the same rate and extent of absorption. Bioequivalence can be assessed through in vivo or in vitro methods. In vivo methods involve pharmacokinetic or pharmacodynamic studies in humans. In vitro methods involve dissolution studies to assess equivalence. The criteria for determining whether in vivo or in vitro studies are needed are described, including factors like dosage form, therapeutic index, and pharmacokinetics of the drug. Biowaivers for in vitro equivalence without in vivo studies are possible under certain specified conditions.
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This document discusses concepts related to bioavailability and bioequivalence studies. It defines key terms like bioavailability and provides an overview of different methods to measure bioavailability including pharmacokinetic methods like plasma level time studies and urinary excretion studies. It also discusses pharmacodynamic methods, in vitro dissolution studies and their relationship to bioavailability, in vitro-in vivo correlations, and different study designs used in bioequivalence studies.
Bioavailability ppt
This document discusses bioavailability and bioequivalence studies. It defines bioavailability as the fraction of a drug that reaches systemic circulation, and bioequivalence as drugs reaching circulation at the same rate and to the same extent. It describes various methods to measure bioavailability including plasma level time studies, urinary excretion studies, and pharmacological or therapeutic response. The document outlines study designs for bioequivalence testing including randomization, cross-over, and Latin square designs. It discusses the importance of these studies for drug development and quality control.
Bioavailability and Bioequivalence
This document provides information about bioavailability and bioequivalence studies. It defines bioavailability as the rate and extent to which a drug enters systemic circulation from a dosage form. Factors influencing bioavailability include pharmaceutical, patient, and route of administration factors. The objectives of bioavailability studies are discussed, including determining the influence of excipients and possible drug interactions. Types of bioavailability study designs covered include absolute vs relative bioavailability, single vs multiple dose studies, and using healthy subjects vs patients. Methods for measuring bioavailability through pharmacokinetic studies of plasma drug levels and urinary excretion studies are also summarized.
Bioequivalence stuides bioequivalance and its importance
Bioequivalence stuides bioequivalance and its importanceLatur college of pharmacy Hasegaon Latur Maharashtra
Bioequivalence studies compare the bioavailability of generic drug products to reference listed drugs. They involve administering test and reference formulations to healthy subjects in a crossover design to determine if the rate and extent of absorption is within an acceptable range, usually 80-125%, of the reference product. If so, the products are considered to be bioequivalent and therapeutically interchangeable.biopharmaceutics ohhhvcc vvcghhccgg.pptx
1. The document discusses bioequivalence, which refers to two drug formulations producing comparable levels of the active substance in the bloodstream and providing equivalent therapeutic effects.
2. It defines bioequivalence and outlines the objectives of bioequivalence studies, which are conducted to establish interchangeability between generic and brand-name drugs.
3. The types of bioequivalence studies discussed are in vivo studies, involving human subjects, and in vitro dissolution testing to compare drug release characteristics. Techniques used include blood sampling, analytical methods like HPLC, and statistical tests to determine bioequivalence.
Bioavailability And Bioequivalence
This document discusses bioavailability and bioequivalence. It defines bioavailability as the rate and amount of drug absorption from its dosage form. Factors that influence bioavailability include pharmaceutical properties, patient factors, and route of administration. Absolute bioavailability compares systemic availability after oral versus intravenous dosing, while relative bioavailability compares oral dosing to an oral standard. Bioequivalence means two products have identical plasma concentration-time profiles without statistical differences. The document outlines methods to measure bioavailability including pharmacokinetic studies using plasma or urine data and pharmacodynamic studies using physiological responses. It also discusses objectives and criteria for bioequivalence studies.
BIOEQUIVALENCE STUDIES.pptx
It refers to the drug substance in two or more identical dosage forms , reaches systemic circulation at he same rate and to the same relative extent .
Their plasma concentration –time profile will be identical without significant statistical differences.
Bioequiuvalence and drug product assessment
This document summarizes the key concepts of bioavailability and bioequivalence studies. It defines bioequivalence as the absence of a significant difference in the rate and extent to which an active drug ingredient becomes available at the site of action when administered in the same molar dose under similar conditions. The document outlines the objectives, types of equivalence studies, statistical evaluation methods, and types of evidence required to establish bioequivalence according to regulatory agencies like FDA and WHO. It also discusses biowaivers and the biopharmaceutics classification system used to determine when in vivo studies can be waived.
Lectures 11 Bioavailability
Bioavailability refers to the amount of drug that enters systemic circulation and is available at the site of action. It depends on the rate and extent of drug absorption from its dosage form. Many physiological and drug-specific factors can affect bioavailability such as pH, enzymes, blood flow, and food interactions. Careful evaluation and standardization of bioavailability is important for drug development and quality control to ensure accurate and safe dosing.
Bioequivalence and drug product assessment
This document provides an overview of bioequivalence and bioavailability studies. It defines key terms like bioequivalence according to FDA and WHO. It discusses the need for bioequivalence studies when developing generic drugs. The objectives and types of bioequivalence studies are outlined, including in vivo, in vitro, and biowaiver approaches. Statistical evaluation of data from various study designs like randomized crossover trials are also summarized. The document concludes with a brief discussion of biowaivers and the biopharmaceutics classification system used to determine when in vivo studies can be waived.
BIOEQUIVALENCE STUDIES.pptx
It refers to the drug substance in two or more identical dosage forms , reaches systemic circulation at he same rate and to the same relative extent .
Their plasma concentration –time profile will be identical without significant statistical differences.
Clinical significance of bioequivalence and biowaivers
1. The document discusses the clinical significance of bioequivalence studies and biowaivers. Bioequivalence studies are conducted to show that generic drug products are equivalent to innovator products in terms of rate and extent of absorption.
2. Biowaivers allow approval of drug applications without conducting in vivo bioequivalence testing based on evidence of equivalence from other factors. The Biopharmaceutics Classification System provides guidelines for biowaivers for certain drug products based on solubility and permeability characteristics.
3. There are limitations to biowaivers such as they are not applicable to locally acting or modified release drug products, or those with a narrow therapeutic index. Biowaivers can help reduce unnecessary exposure of subjects to
BIOAVAILABILTY AND BIOEQUIVALENCE STUDY
This document discusses bioavailability and bioequivalence studies. It defines bioavailability as the rate and extent of absorption of a drug from its dosage form and defines bioequivalence as two or more identical drug products reaching systemic circulation at the same rate and to the same relative extent. The document outlines various methods to assess bioavailability including plasma level-time studies and urinary excretion studies. It also discusses the objectives and types of bioequivalence studies, including in vivo and in vitro methods.
Bioavailability and Bioequivalence detail.pdf
I am a pharmacist. These slides describe detail topic of biopharmaceutics topic. I hope pharmacy department students get more benefits about it.
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Bioequivalence stuides bioequivalance and its importance
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Clinical significance of bioequivalence and biowaivers
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Bioequivalence studies
- 1. Presented By Debottam Das 3rd Year, 6th semester ROLL-20801914030
- 2. Introduction Definitions Advantages/ Disadvantages Requirements/Objectives Bioequivalence problems Types of Bioequivalence In vivo In vitro
- 3. Bioequivalence is a comparison of bioavailability of two or more product i.e. Formulation containing the same active ingredient are said to be bio- equivalent if their rate and extent of absorption is same. Bioequivalence is receiving increasing attention because of increased availability and importance of generic drugs in today’s pharmaceutical market. Bio-equivalence studies are generally used to compare two products so as to compare their biological equivalence.
- 4. It refers to the drug substance in two or more identical dosage forms, reaches systemic circulation at the same rate and to the same relative extent.
- 5. Minimizes the effect of inter subject variability. It minimizes the carry over effect. Requires less number of subjects to get meaningful result.
- 6. Requires longer time to complete the studies. Completion of studies depends on number of formulations evaluated in the studies. Increase in study period leads to high subject dropouts. Medical ethics does not allow too many trials on a subject continuously for a longer time.
- 7. If a new product is intended to be a substitute for an approved medicinal product as a pharmaceutical equivalent or alternative, the equivalence with this product should be shown or justified. In order to ensure clinical performance of such drug products, bioequivalence studies should be performed. Bioequivalence studies are conducted if there is a risk of pharmacotherapeutic failure or diminished clinical safety.
- 8. Bioequivalence problem occurs due to following reason- Active drug ingredient has low solubility in water. (less than 5mg/ml). Specific ingredients such as hydrophilic & hydrophobic excipient & lubricant may interfere with absorption. Active ingredients absorbed in particular segment of GIT. The degree of absorption of active drug ingredient is poor when administered in pure form.
- 9. Bioequivalence can be demonstrated either- In vivo, or In vitro
- 10. The following sequence of criteria is useful in assessing the need for in vivo studies: 1. Oral immediate-release products with systemic action- Indicated for serious conditions requiring assured response. Narrow therapeutic margin. Pharmacokinetics complicated by absorption<70% or absorption window, nonlinear kinetics, presystemic elimination>70%.
- 11. Unfavorable physicochemical properties, e.g. low solubility, metastable modification, instability ,etc. Documented evidence for bioavailability problems. No relevant data available, justification by applicant that in vivo study is not necessary. 2. Non-oral immediate-release products. 3. Modified-release products with systemic action.
- 12. In vivo bioequivalence studies are conducted in the usual manner as discussed for bioavailability studies, i.e. the pharmacokinetic and the pharmacodynamic methods. 1. Pharmacokinetic Methods a) Plasma level-time studies b) Urinary Excretion studies 2. Pharmacodynamic Methods a) Acute pharmacological response b) Therapeutic response
- 13. If none of the above criteria is applicable, comparative in vitro dissolution studies will suffice. In vitro studies, i.e. dissolution studies can be used in lieu of in vivo bioequivalence under certain circumtances, called as biowaivers (exemptions)- 1. The drug product differs only in strength of the active substance it contains, provided all the following conditions hold-
- 14. Pharmacokinetics are linear. The qualitative composition is the same. Both products are produced by the same manufacturer at the same production site. 2. The drug product meets all of the following requirements- The product is in the form of solution or solubilised form(elixir, syrup, tincture,etc). The product contains active ingredient in the same concentration as the approved drug product. The product contains no excipients known to significantly affect absorption of the active ingredient.
- 16. “Biopharmaceutics and Pharmacokinetics -A Treatise” by D. M. Brahmankar & Sunil B. Jaiswal Delhi Vallabh Prakashan, 3rd Edition. www.google.com