This document discusses in vitro-in vivo correlation (IVIVC), which aims to develop a mathematical model that correlates an in vitro property like drug dissolution rate/extent to an in vivo response like plasma drug concentration or amount absorbed. The main objective is for dissolution tests to serve as a surrogate for in vivo bioavailability studies in humans. There are different levels of IVIVC from A to C, with level A representing a point-to-point relationship between in vitro dissolution and in vivo absorption rate. The document also discusses applications of IVIVC and the biopharmaceutics drug classification system for extended release products.
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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)
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.
The main objective of developing and evaluating an IVIVC is to enable the
dissolution test to serve as a surrogate (alternate) for in vivo bioavailability studies in
human beings.
The applications of developing such an IVIVC are —
1. To ensure batch-to-batch consistency in the physiological performance of a drug
product by use of such in vitro values.
2. To serve as a tool in the development of a new dosage form with desired in vivo
performance.
3. To assist in validating or setting dissolution specifications (i.e. the dissolution
specifications are based on the performance of product in vivo).
There are two basic approaches by which a correlation between dissolution testing
and bioavailability can be developed:
1. By establishing a relationship, usually linear, between the in vitro dissolution and
the in vivo bioavailability parameters.
2. By using the data from previous bioavailability studies to modify the dissolution
methodology in order to arrive at meaningful in vitro-in vivo correlation.
An in vitro – in vivo correlation (IVIVC) is defined as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.
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) definitionIVIVC 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.
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".
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)”.
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)
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.
The main objective of developing and evaluating an IVIVC is to enable the
dissolution test to serve as a surrogate (alternate) for in vivo bioavailability studies in
human beings.
The applications of developing such an IVIVC are —
1. To ensure batch-to-batch consistency in the physiological performance of a drug
product by use of such in vitro values.
2. To serve as a tool in the development of a new dosage form with desired in vivo
performance.
3. To assist in validating or setting dissolution specifications (i.e. the dissolution
specifications are based on the performance of product in vivo).
There are two basic approaches by which a correlation between dissolution testing
and bioavailability can be developed:
1. By establishing a relationship, usually linear, between the in vitro dissolution and
the in vivo bioavailability parameters.
2. By using the data from previous bioavailability studies to modify the dissolution
methodology in order to arrive at meaningful in vitro-in vivo correlation.
An in vitro – in vivo correlation (IVIVC) is defined as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.
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) definitionIVIVC 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.
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".
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)”.
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.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
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Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Instructions for Submissions thorugh G- Classroom.pptx
INVITRO-INVIBO CORELATION
1. Dr.Syed Umar Farooq
Department of pharmaceutics
Care college of Pharmacy
In Vitro—In Vivo C
orrelation (IVIVC)
ALLPPT.com _ Free PowerPoint Templates, Diagrams and Charts
2. Definition
In vitro-in vivo correlation is defined as the predictive mathematical model
that describes the relationship between an in-vitro property (such as the rat
e and extent of dissolution) of a dosage form and an in-vivo response (such
as the plasma drug concentration or amount of drug absorbed).
3. Objective
The main objective of developing and evaluating an IVIVC is t
o enable the dissolution test to serve as a surrogate (alternate)
for in vivo bioavailability studies in human beings
4. Applications
The applications of developing such an IVIVC are —
To ensure batch-to-batch consistency in the physiological per
formance of a drug product by use of such in vitro values.
To serve as a tool in the development of a new dosage form
with desired in vivo performance.
To assist in validating or setting dissolution specifications (i.e
. the dissolution specifications are based on the performance
of product in vivo).
5. Approaches
There are two basic approaches by which a correlation betwe
en dissolution testing and bioavailability can be developed:
By establishing a relationship, usually linear, between the in vi
tro dissolution and the in vivo bioavailability parameters.
By using the data from previous bioavailability studies to mod
ify the dissolution methodology in order to arrive at meaningf
ul in vitro-in vivo correlation.
6. Quantitative linear in vitro-in vivo correlations are
Correlations Based on the Plasma Level Data: Here line
ar relationships between dissolution parameters such as per
cent drug dissolved, rate of dissolution, rate constant for dis
solution, etc. and parameters obtained from plasma level da
ta such as percent drug absorbed, rate of absorption, Cmax,
tmax, Ka, etc. are developed; for example, percent drug dis
solved versus percent drug absorbed plots
7. Correlation Based on the Urinary Excretion Data: Here,
dissolution parameters are correlated to the amount of drug
excreted unchanged in the urine, cumulative amount of dru
g excreted as a function of time, etc.
Correlation Based on the Pharmacological Response: A
n acute pharmacological effect such as LD50 in animals is r
elated to any of the dissolution parameters.
8. IN VITRO-IN VIVO CORRELATION LEVELS
Level A – The Highest Category Of Correlation, It Repres
ents A Point-to-point Relationship Between In Vitro Dissol
ution And The In Vivo Rate Of Absorption (Or In Vivo Diss
olution) I.E. The In Vitro Dissolution And In Vivo Absorpti
on Rate Curves Are Superimposable And The Mathematica
l Description For Both Curves Is The Same.
9. LEVEL B – Utilises The Principles Of Statistical Moment Anal
ysis. The Mean In Vitro Dissolution Time Is Compared To Eith
er The Mean Residence Time Or The Mean In Vivo Dissolutio
n Time. However, Such A Correlation Is Not A Point-to-point
Correlation Since There Are A Number Of In Vivo Curves That
Will Produce Similar Mean Residence Time Values. It Is For T
his Reason That One Cannot Rely Upon Level B Correlation T
o Justify Changes In Manufacturing Or Modification In Formu
la. Moreover, The In Vitro Data Cannot Be Used For Quality C
ontrol Standards. At Various Time Points.
10. LEVEL C – It Is A Single Point Correlation. It Relates One D
issolution Time Point (E.G. T50%, Etc.) To One Pharmacokinet
ic Parameter Such As AUC, Tmax Or Cmax. This Level Is Gener
ally Useful Only As A Guide In Formulation Development Or
Quality Control Owing To Its Obvious Limitations.
MULTIPLE LEVEL C – It Is Correlation Involving One Or
Several Pharmacokinetic Parameters To The Amount Of Drug
Dissolved
11. Bio pharmaceutics Drug Classification System
for Extended Release Drug Products
Class Solubility Permeability IVIVC
Ia High and site I
ndependent
High and site independ
ent
IVIVC Level A
expected
Ib High and site
independent
Dependent on site and
narrow absorption wind
ow
IVIVC Level C
expected
IIa Low and site
independent
High and site independ
ent
IVIVC Level A
expected
IIb Low and site
independent
Dependent on site and
narrow absorption wind
ow
Little or no IVIVC
Va: Acidic Variable Variable Little or no IVIVC
Vb: basic Variable Variable IVIVC Level A
expected