Bioavailability is rate and extent of drug absorption
The relative amount of administered dose of drug that reaches to its site of action from the site and dose of administration in an unchanged form. The rate at which this phenomenon occurs is known as BIOAVAILABILITY
Here site of action refers to plasma or systemic circulation and unchanged form refers to therapeutically active form
Bioavailabile Dose:- Fraction of administered dose of drug which reaches to site of action is bioavailable dose.
GIT ABSORPTION FOR ORAL Administered DrugAli Mashwani
In this Lecture I have covered how the Drug is absorbed when it is administered orally, what is BCS classification system, Role of BCS and Importance of Biopharmaceutics Classification System. I have discussed how the Pharmakinetics process occur, what is Absorption, Distribution, Metabolism and Excretion.
Fundamental concept of modified drug releaseAbhinayJha3
Different Terminologies used in a modified release
1. Sustained release
2. Delayed release
3. Prolonged release
4. Extended-release
5. Controlled release
6. Site-specific targeting and receptor targeting
SELECTION OF DRUG CANDIDATE FOR ORAL SUSTAINED RELEASE SYSTEMS, BIOPHARMACEUTICAL CLASSIFICATION SYSTEM.
Fundamental concept of modified drug releaseAbhinayJha3
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
Different Terminologies used in a modified release
1. Sustained release
2. Delayed release
3. Prolonged release
4. Extended-release
5. Controlled release
6. Site-specific targeting and receptor targeting
General Pharmacology Lecture Slides on Bioavailability and Bioequivalence by Sanjaya Mani Dixit Assistant Professor of Pharmacology at Kathmandu Medical College
Relation between biopharmaceutics and Dosage form design MdJahangirAlam110
If you try to gain proper knowledge about the relation between biopharmaceutics and Dosage form design then this assignment hopefully helpful for you . Here you find data about the biopharmaceutics and its factors, bioavailability, dosage form design ,factors influencing ADME and therapeutic activity of drug .which dosage form having good bioavailability and therapeutic effect and shows 1st onset of action .
If you find any wrong information please inform me and pardon my mistake .
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption.
Bioavailability and bioequivalence
Bioavailability-
Whenever a drug is given by oral route it has to go through certain pathway to reach the systemic circulation. Eg. If 100 mg drug is given orally, and if 80 mg is absorbed and 20 mg gets excreted then 80 mg absorbed drug reaches liver through portal system. In liver it gets metabolized, here if 30 mg gets metabolized by the liver 50 mg reaches the systemic circulation in the unchanged from. But Bioavailability is expressed in mg it has to be expressed in fraction. So Bioavailability is basically the fraction of unchanged from of the drug that reaches the systemic circulation following administration by any route.
As the drug given by intravenous route reaches directly into the systemic circulation. So the Bioavailability of drug given i.v is 100 %. % Bioavailability can be calculated as- Area under the curve (AUC oral)/ (AUC i.v) *100.
Bioavailability depends on both the rate and extent of absorption.
Rate of absorption depends on- site of adminstration and the drug formulation.
Extent (amount) of absorption depends on- route of drug administration
Factors affecting absorption and Bioavailability-
Pharmaceutical and pharmacological factors:
Pharmaceutical factors include- particle size, crystal from, salt form, water of hydration, Nature of excipients and adjuvants, degree of ionisation.
Pharmacological factors- gastric emptying & g.i mobility, g.i diseases, food and other substances, first-pass effect, Drug-drug interaction, pharmacogenetics, miscellaneous factors like route of administration, area of absorbing surface, state of circulation at site of absorption.
Whenever a drug is given orally it has to go through certain pathway to reach systemic circulation.
E.g out of 100 mg drug given orally if 80 mg gets absorbed & 20 gets excreted. 80 mg of absorbed drug then reaches the liver through portal vein. Liver is highly saturated with enzymes so it doesn't allow the drug to pass freely through it without metabolizing certain amount of drug. . So if 30 mg of absorbed drug gets metabolized in the liver remaining 50 mg of drug reaches the systemic circulation in the unchanged form. But Bioavailability is never expressed in mg it is always expressed in fraction. So Bioavailability is basically the fraction of unchanged from of the drug that reaches the systemic circulation following administration by any route.
Whenever drug is given intravenously 100% drug reaches the systemic circulation in an unchanged form. So the Bioavailability of the drug given intravenously is 100%, while that of the drug given orally is < 100%
Bioavailability of a drug depends on the rate and extent of absorption.
Rate of drug administration is determined by: site of drug administration and drug formulation.
Extent (amount) of drug absorption is determined by: route of drug administration.
Factors affecting drug absorption and Bioavailability- There are various pharmaceutical and pharmacological factors that affect the drug absorption.
FIRST PASS METABOLISM:-
The drug given orally first pass through GI wall and then reaches the liver through portal system. The drug can also be metabolized in the gut wall CYP3A4 enzyme which is a substrate for P-gp {P-glycoprotein (P-gp) is an active transporter which pumps drug out of the gut wall cells back into the gut lumen against the concentration gradient.) Normally, drug enters the intestinal lumen by passive diffusion (i.e along the concentration gradient). But P-gp causes drug efflux or drug wastage (i.e against the concentration gradient); The amount of drug that disappears contribute first pass metabolism. But first pass metabolism occur in LIVER > INTESTINE.
Some amount of drug while passing through the liver gets metabolized in the liver for the first time before reaching the systemic circulation this known as first pass metabolism.
Bioequivalence- it as comparison of 2 different brand products of a same drug.
E.g. if Drug company X designs a new drug - (BRANDED DRUG) it gets patency for suppose 20 yrs. So that no other company can legally copy this drug. But once the patency expires any other company can legally copy this drug (GENERIC DRUG) but requires approval by FDA. and FDA asks for BIOEQUIVALENCE certificate (i.e it checks if the compound produced by other company is equivalent to that of BRANDED DRUG.) It has to prove that amount as well as rate of absorption is similar. No company can copy the drug 100% as it is. therefore the acceptable range is +/- 20-25%. The drug can be chemically, pharmaceutically, Therapeutically & clinically equivalent.
Thank you
Lecture Objectives
After completion of lecture, students will be able to:
• Describe bioavailability, bioequivalence, Half-life, Loading & Maintenance
Dose
• Explain why certain drugs have low bioavailability.
• Explain factors affecting bioavailability.
• Describe clinical importance of bioavailability, bioequivalence, Half-life,
Loading & Maintenance Dose
As a matter of fact basti is the most important item among the samshodhana procedures. However the term basti is derived from the fact that the basti yantra or the apparatus used for introducing the medicated materials is made up of basti or animal urinary bladder. Generally a basti is applied through the rectum though it may also be applied for urethra. In such cases the term Uttara basti is applied.
Depending upon the use of different drugs, basti effects samshodhana of doshas. It has also samshamana effects. Thus basti in its different forms has very wide application.
Aushada is one which can be taken in disease, in alpha matra, even in severe condition, many doshas involved. Taken in specific disease, aushada which is of good quality, in proper dose should destroy it, without any complications.
GIT ABSORPTION FOR ORAL Administered DrugAli Mashwani
In this Lecture I have covered how the Drug is absorbed when it is administered orally, what is BCS classification system, Role of BCS and Importance of Biopharmaceutics Classification System. I have discussed how the Pharmakinetics process occur, what is Absorption, Distribution, Metabolism and Excretion.
Fundamental concept of modified drug releaseAbhinayJha3
Different Terminologies used in a modified release
1. Sustained release
2. Delayed release
3. Prolonged release
4. Extended-release
5. Controlled release
6. Site-specific targeting and receptor targeting
SELECTION OF DRUG CANDIDATE FOR ORAL SUSTAINED RELEASE SYSTEMS, BIOPHARMACEUTICAL CLASSIFICATION SYSTEM.
Fundamental concept of modified drug releaseAbhinayJha3
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
Different Terminologies used in a modified release
1. Sustained release
2. Delayed release
3. Prolonged release
4. Extended-release
5. Controlled release
6. Site-specific targeting and receptor targeting
General Pharmacology Lecture Slides on Bioavailability and Bioequivalence by Sanjaya Mani Dixit Assistant Professor of Pharmacology at Kathmandu Medical College
Relation between biopharmaceutics and Dosage form design MdJahangirAlam110
If you try to gain proper knowledge about the relation between biopharmaceutics and Dosage form design then this assignment hopefully helpful for you . Here you find data about the biopharmaceutics and its factors, bioavailability, dosage form design ,factors influencing ADME and therapeutic activity of drug .which dosage form having good bioavailability and therapeutic effect and shows 1st onset of action .
If you find any wrong information please inform me and pardon my mistake .
Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption.
Bioavailability and bioequivalence
Bioavailability-
Whenever a drug is given by oral route it has to go through certain pathway to reach the systemic circulation. Eg. If 100 mg drug is given orally, and if 80 mg is absorbed and 20 mg gets excreted then 80 mg absorbed drug reaches liver through portal system. In liver it gets metabolized, here if 30 mg gets metabolized by the liver 50 mg reaches the systemic circulation in the unchanged from. But Bioavailability is expressed in mg it has to be expressed in fraction. So Bioavailability is basically the fraction of unchanged from of the drug that reaches the systemic circulation following administration by any route.
As the drug given by intravenous route reaches directly into the systemic circulation. So the Bioavailability of drug given i.v is 100 %. % Bioavailability can be calculated as- Area under the curve (AUC oral)/ (AUC i.v) *100.
Bioavailability depends on both the rate and extent of absorption.
Rate of absorption depends on- site of adminstration and the drug formulation.
Extent (amount) of absorption depends on- route of drug administration
Factors affecting absorption and Bioavailability-
Pharmaceutical and pharmacological factors:
Pharmaceutical factors include- particle size, crystal from, salt form, water of hydration, Nature of excipients and adjuvants, degree of ionisation.
Pharmacological factors- gastric emptying & g.i mobility, g.i diseases, food and other substances, first-pass effect, Drug-drug interaction, pharmacogenetics, miscellaneous factors like route of administration, area of absorbing surface, state of circulation at site of absorption.
Whenever a drug is given orally it has to go through certain pathway to reach systemic circulation.
E.g out of 100 mg drug given orally if 80 mg gets absorbed & 20 gets excreted. 80 mg of absorbed drug then reaches the liver through portal vein. Liver is highly saturated with enzymes so it doesn't allow the drug to pass freely through it without metabolizing certain amount of drug. . So if 30 mg of absorbed drug gets metabolized in the liver remaining 50 mg of drug reaches the systemic circulation in the unchanged form. But Bioavailability is never expressed in mg it is always expressed in fraction. So Bioavailability is basically the fraction of unchanged from of the drug that reaches the systemic circulation following administration by any route.
Whenever drug is given intravenously 100% drug reaches the systemic circulation in an unchanged form. So the Bioavailability of the drug given intravenously is 100%, while that of the drug given orally is < 100%
Bioavailability of a drug depends on the rate and extent of absorption.
Rate of drug administration is determined by: site of drug administration and drug formulation.
Extent (amount) of drug absorption is determined by: route of drug administration.
Factors affecting drug absorption and Bioavailability- There are various pharmaceutical and pharmacological factors that affect the drug absorption.
FIRST PASS METABOLISM:-
The drug given orally first pass through GI wall and then reaches the liver through portal system. The drug can also be metabolized in the gut wall CYP3A4 enzyme which is a substrate for P-gp {P-glycoprotein (P-gp) is an active transporter which pumps drug out of the gut wall cells back into the gut lumen against the concentration gradient.) Normally, drug enters the intestinal lumen by passive diffusion (i.e along the concentration gradient). But P-gp causes drug efflux or drug wastage (i.e against the concentration gradient); The amount of drug that disappears contribute first pass metabolism. But first pass metabolism occur in LIVER > INTESTINE.
Some amount of drug while passing through the liver gets metabolized in the liver for the first time before reaching the systemic circulation this known as first pass metabolism.
Bioequivalence- it as comparison of 2 different brand products of a same drug.
E.g. if Drug company X designs a new drug - (BRANDED DRUG) it gets patency for suppose 20 yrs. So that no other company can legally copy this drug. But once the patency expires any other company can legally copy this drug (GENERIC DRUG) but requires approval by FDA. and FDA asks for BIOEQUIVALENCE certificate (i.e it checks if the compound produced by other company is equivalent to that of BRANDED DRUG.) It has to prove that amount as well as rate of absorption is similar. No company can copy the drug 100% as it is. therefore the acceptable range is +/- 20-25%. The drug can be chemically, pharmaceutically, Therapeutically & clinically equivalent.
Thank you
Lecture Objectives
After completion of lecture, students will be able to:
• Describe bioavailability, bioequivalence, Half-life, Loading & Maintenance
Dose
• Explain why certain drugs have low bioavailability.
• Explain factors affecting bioavailability.
• Describe clinical importance of bioavailability, bioequivalence, Half-life,
Loading & Maintenance Dose
As a matter of fact basti is the most important item among the samshodhana procedures. However the term basti is derived from the fact that the basti yantra or the apparatus used for introducing the medicated materials is made up of basti or animal urinary bladder. Generally a basti is applied through the rectum though it may also be applied for urethra. In such cases the term Uttara basti is applied.
Depending upon the use of different drugs, basti effects samshodhana of doshas. It has also samshamana effects. Thus basti in its different forms has very wide application.
Aushada is one which can be taken in disease, in alpha matra, even in severe condition, many doshas involved. Taken in specific disease, aushada which is of good quality, in proper dose should destroy it, without any complications.
AVARTANA TECHNOLOGY IN PHARMACEUTICAL PREPARATIONS.pptxDr Priyanka Patil
The Avartana technology is the method in which repeated processing of a Sneha is done with prescribed Kalka and Drava dravya and heating it to a specific number of times.
refractive index, pH, specific gravity, viscosity, alcohol content, fineness of the particles, saponification value, Acid value, iodine value, Reducing sugars, quantitative inorganic analysis, loss on drying, determination of ash value.
Arshas/ Haemorroids most disturbing disease of this generation. Kasisa drava basti is ayurvedic line of treatment of piles. its rasoushadhi mention in rasatarangini.
Immunomodulators in ayurveda, disease curing way of ayurveda. ancient health science role in prevention of disease & its management .Ayurvedic Energy boosters
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cohort study represent fundamental designs of epidemiology in field of medicine, social science & psychology.
Distillation oldest separation process. used in unit of industries even in pharma industry for preparation of medicines. it is based on the difference in the boiling point.
Ayurvedic Herbo- mineral medicine indicated in cerebrovascular Stroke/ Haemiplagia or paralysis. facial paralysis & neuromuscular disorders. Rasoushadi indicated in vatavyadi.
Very popular Ayurvedic oil preparation indicated in osteoarthritis, rheumatic arthritis, edema & movement restriction. Mainly helpful in relieving pain. it is mentioned in Sahasrayoga Book.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
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Palestine last event orientationfvgnh .pptxRaedMohamed3
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This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
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2. INTRODUCTION:
In any medical field oral route of drug administration is
considered as a major route and has been practicing widely. A
basic assumption is that a when a drug is administered orally
the dosage form of that releases and absorbs completely and
promptly. But is not so. Many of the drugs are not absorbed to
the desired extent due to the factors related to drug, dosage
form, physiological factors etc. In such cases, concepts of
Bioavailability and Bioequivalence become important
consideration in assuring the optimal and consistent drug
absorption.
3. What Is BIOAVAILABILITY?
Bioavailability is rate and extent of drug absorption.
The relative amount of administered dose of drug that reaches
to its site of action from the site and dose of administration in
an unchanged form. The rate at which this phenomenon
occurs is known as BIOAVAILABILITY.
Here site of action refers to plasma or systemic circulation and
unchanged form refers to therapeutically active form.
Bioavailabile Dose:- Fraction of administered dose of drug
which reaches to site of action is bioavailable dose.
4. Why do we care for BIOAVAILABILITY?
True dose of drug is not the drug swallowed but it is the
drug available to exert its effect.
Bioavailability does not only depend on the dose
administered, but also on the fraction of that is absorbed
and escapes any first pass metabolism and elimination.
Therefore for 100% bioavailability of a drug, entire drug
must move from dosage form to the systemic circulation.
5. Factors Influencing The Bioavailability:
Food eaten by the patient
Age of the patient
Affect of the disease state
Dosage form
Instability of the drug in G.I fluids
Physiochemical characters of the drug
Method of manufacture
Size of the dose
Frequency of the dose
Route of administration
Environmental conditions in G.I.T
6. Food and Bioavailability
Food may increase or decrease or may not affect on
bioavailability.
It may increase G.I motility and hence increase solubility.
Complication of a drug (binding of a drug molecule with
food).
Alter gastric pH and stimulate gastric secretion.
Food may tend to vomiting which decrease bioavailability.
7. Dosage form and Bioavailability
In general drugs must be in solution of in G.I fluids before it
gets absorbed.
Type of dosage form and its manufacture methods can
influence bioavailability thus weather drug is administered in
the form of solution/suspension/solid dosage form can affect
bio availability.
The stage between administration and absorption are directly
depend on dosage form.
Hence bioavailability of drug dosage form will be in
following order
Aqueous solution> aqueous suspension > solid dosage form
Excipients like lubricants, coloring agents, flavoring agents
etc. can also influence bioavailability.
8. Routeof Drug Administrationand Bioavailability
Rapid and maximum BA of a drug is affected markedly by
route of administration.
Difference in plasma conc. Of a drug depends on number and
nature of membrane across its must transported before reaches
to plasma.
Drug administered through I.V is not subjected to any
transport process so that maximum BA is attained immediately
with entire dose
9. Route of Drug Administration And
Bioavailability:
Absorption through I.M, S.C route is less bioavailable
than I.V route since they involve transport across
membrane barrier.
I.M route gives more rapid bioavailability than S.C
route because skeletal muscles have a better blood
supply than S.C tissue.
These routes also provide rapid absorption with little
lose of drug.
It should be kept in mind that the nature of specific
drug may alter the absorption through these routes
because of local binding of the drug.
10. Rectal Route and Bioavailability:
Only 50% of the drug is absorbed through
rectal route because the drug will undergo first
pass metabolism through liver.
Trough this route, rate of absorption of the
drug is very rapid because of high vascularity.
11. Oral drug administration and B.A.
Stages involved:-
Disintegration:- solid dosage form of the drug break into
individual particles of active form
Dissolution:- Disintegrated drug will dissolved into aqueous
G.I. fluid
Absorption:- dissolved drug then absorbed by the G.I.T.
Bioavailability:- absorbed drug then reaches to systemic
circulation.
12. Effects of Oral drug administration on B.A.
BA may be incomplete through oral route because of,
Stomach contents
Environmental conditions in G.I.T.
Incomplete absorption of drug by the gut
First pass metabolism in gut wall/liver
Rapid emptying of intestine
Instability of drug in G.I fluids.
Solubility of drug in G.I fluids
Emesis because of G.I mucosa.
13. Criteria for an Ideal Oral Drug
Ideal oral drug is the one which must be 100% bioavailable i.e.
the entire drug must move from dosage form to systemic
circulation. Hence the drug must be,
Completely released from dosage form.
Fully dissolved in G.I fluids.
Stable in solution in G.I. fluids
Pass through gastro intestinal barriers into mesenteric
circulation without metabolism.
Pass through liver unchanged into systemic circulation.
14. Why BA vary in oral drug administration?
Disintegration:-
Nature of binders, diluents, lubricants etc
Manufacturing process (eg:-force used to compress the
tablet)
Dissolution:-
Solubility of the drug
Particle size
Crystal form etc.
Absorption
Poorly soluble and slowly absorbed drugs show
difference in bioavailability.
15. Significance of Variance in BA
Variability in BA can cause plasma concentration of
the drug too high & hence can cause side effects OR
too low & therefore the drug may be inactive.
BA variance is more significance for the drugs with
low safety margin or where drug dosage needs precise
control.
16. Why assessment of BA is necessary?
Measurement of BA gives net results of the effect of the
release of drug into solution in the physiological fluid at the
site of absorption.
Stability of the drug in the physiological fluid can be
determined.
Permeability and pre systemic metabolism and rate & extent of
drug absorption is known
It gives information on other pharmacokinetic parameters such
as distribution, metabolism, and elimination of the drug
17. (contd….)
Maximum safe concentration of the drug in plasma can be
assumed above which side effects are expected.
The time required to achieve minimum effective
concentration, peak concentration, duration of the
therapeutic effective period of the drug can be assumed
which is very essential in clinical practice.
BA study serves as a benchmark for subsequent BE
studies.
Comparison of BA assessment of 2 or more chemically
equivalent drugs or pharmaceutical alternatives is nothing
but BE study.
18. How to assess BA?
Well controlled animal study.
Well controlled clinical trials in human.
Plasma concentration time curve.
Excretion of drug through urine.
19. Plasma Concentration Time Curve:
When a single dose of drug is administered to a patient, serial
blood samples are withdrawn for a constant intervals of time
and plasma is assayed for drug and the values are graphically
represented which is known as Plasma Concentration Time
Curve.
In this curve time taken to reach max concentration of drug is
represented as Tmax
Peak concentration of the drug in plasma is termed as Cmax
20. Factors effecting Plasma Concentration of the Drug:
• Drug concentration is related to the level of activity of drug.
• Plasma Concentration of the Drug is mainly affected by the
rate at which it is absorbed into plasma and the rate at which
the drug is eliminated by excretion or biotransformation.
• Distribution of the drug between plasma to other tissues also
will affect the plasma concentration of the drug.
21. Determination of BA through Urine:
The amount of drug eventually excreted in an
unchanged form in urine shows the percentage of the
dose reached to systemic circulation.
22. Absolute Bioavailability
The fraction or the percentage of the administered
dose of the drug absorbed intact into systemic
circulation is Absolute Bioavailability.
It can be calculated by comparing the total amount of
intact drug reaches to the systemic circulation after
administration of a known dose of the dosage form
via a route of administration with that of I.V. route
with same dose.
Here I.V route is considered to be ideal to compare
with other routes because of its 100% bioavailability.
23. Relative Bioavailability
It is a measurement of fraction of drug absorbed
intact into systemic circulation from a dosage form
relative to standard (clinically proven) dosage form
of the drug.
in case of drugs that can not be administered
through IV route then the relative bioavailability is
determined rather than absolute bioavailability
In such case BA of drug from test dosage form is
compared with same drug administered in a standard
dosage form that is route from which drug is known
to be well absorbed and efficacy is clinically proved.
24. Concept of Equivalence :
In pharmaceutics Equivalence is a general term that
indicates a comparison of one drug product with another
with an established set of standards.
It may be defined in several ways….
Chemical Equivalence:- 2 or more dosage forms contain
same chemical components or labeled quantities of the
drug
Clinical Equivalence:- the same drug from 2 or more
dosage forms give identical in vivo effects on a symptom
or a disease.
Therapeutic Equivalence:- 2 brands of a same drug
product are expected to yield same clinical results.
25. Pharmaceutical Equivalence:
If 2 or more drugs contain the same active ingredients,
identical in strength (concentration), dosage form and route of
administration
Bioequivalence:
o 2 pharmaceutically Equivalent drugs are considered to be
Bioequivalent when the rate and extent of absorption of their
active ingredients are not significantly differ under similar
experimental conditions.
26. How to conduct BE studies?
In conducting BE study one of the chemically equivalent drug
products which is chemically proven for its therapeutic
efficacy serves as a standard against which the other test
product may be compared.
Comparison between following parameters must be done.
Max plasma concentration Cmax
Time of peak concentration Tmax
Area under plasma concentration time curve (AUC)
If there is no significant deference between these parameters
then both the drugs can be considered as bioequivalent.
If the test product is found to be bioequivalent to the standard
product then it can be expected that the test product is
therapeutically effective as that of standard product.
27. BA Versus BE
Bioequivalence is an extension of the concept of
relative bioavailability, in which the test product is
compared with a standard product for its
Bioavailability.
In other words, Bioequivalence Study is a
comparative Bioavailability Study designed to
establish equivalence between 2 medicinal products,
i.e. test product and clinically proved standard
product.
28. Bioequivalence in terms of Bioavailability
If 2 medicinal products are bioequivalent, if they are
pharmaceutically equivalent or alternatives and their
bio availabilities are identical in the same dose with
respect to both safety and efficacy.
29. Application of concepts of BA&BE IN rasashastra
Concept of pratinidhi dravyas. eg:-mukta & mukta shukti
Bhasma prepared by different procedures. Eg:- kupi & puta
method
Bhasma prepared by different media. Eg: Gandhaka media,
mulika media, parada media, ariloha marita bhasmas
Bhasma after several putas. Eg:- abhraka bhasma after 10 puta,
100 puta,1000 puta.
30. Cont…
Comparative BA studies are essential for rasa dravyas
with same chemical components
Differenet raw meterials. Eg:- abhraka bhasma, loha
bhasma, mandura bhasma, kasisa bhasma. OR all
sudhavargiya drayas
Different methods of preperation
Bahuguna gandhaka jarita parada
Raw material collected from different place
31. Goal of Bioequivalence Study:
BE studies are important in determining whether
chemically equivalent products manufactured by
different companies are therapeutically equivalent
that is produce identical therapeutical response in a
patient.
To establish a new product or formulation which has
same therapeutic equivalence in the rate and extent of
absorption to the reference drug product.
32. Goal of BA & BE studies:
The ultimate goal of bioavailability and
bioequivalence studies is for the safe and
efficacious drug product.