This document discusses bioequivalence studies and various related topics. It begins with definitions of different types of equivalence - chemical, pharmaceutical, therapeutic, and bioequivalence. It then discusses study design considerations, parameters evaluated in bioequivalence studies such as AUC and Cmax, and alternative approaches to in vivo studies including in vitro dissolution testing and biowaivers. Key points covered include the 90% confidence interval criteria applied to determine bioequivalence, crossover vs parallel study designs, and situations where in vitro methods may be acceptable for demonstrating equivalence.
Biopharmaceutics Classification System (BCS) & Waiver of BioequivalenceAjaz Hussain
Graduate Lecture at the University of Maryland (August 2012). Learning Objective: Identify and explain how future regulatory applications of BCS may be realized in the context of ‘Quality by Design’.
Updated July 2013.
I wish to thank all the viewers of my Slideshare presentation of the development and application of the US FDA’s BCS Guidance 2000. Over 11K views have been recorded making this the 2nd highest viewed presentation. FDA is expected to issue a revised BCS draft guidance in the next few weeks. Expected changes include the following:
1. Addition of ‘very rapid’ dissolution criteria (>85% in 15 minutes)
2. Change permeability boundary from 90% to 85%
3. Change the pH solubility range from 1 – 7.5 to 1 – 6.8
4. Possibility of changing paddle speed from 50 to 75 rpm.
5. Additional topics / clarification on FDCs (Fixed Dose Combinations), ODTs (Orally Disintegrating Tablets), MR (Modified Release) products.
6. Update the list of model drugs.
7. Strengthen GI stability requirement.
Biopharmaceutics Classification System (BCS) & Waiver of BioequivalenceAjaz Hussain
Graduate Lecture at the University of Maryland (August 2012). Learning Objective: Identify and explain how future regulatory applications of BCS may be realized in the context of ‘Quality by Design’.
Updated July 2013.
I wish to thank all the viewers of my Slideshare presentation of the development and application of the US FDA’s BCS Guidance 2000. Over 11K views have been recorded making this the 2nd highest viewed presentation. FDA is expected to issue a revised BCS draft guidance in the next few weeks. Expected changes include the following:
1. Addition of ‘very rapid’ dissolution criteria (>85% in 15 minutes)
2. Change permeability boundary from 90% to 85%
3. Change the pH solubility range from 1 – 7.5 to 1 – 6.8
4. Possibility of changing paddle speed from 50 to 75 rpm.
5. Additional topics / clarification on FDCs (Fixed Dose Combinations), ODTs (Orally Disintegrating Tablets), MR (Modified Release) products.
6. Update the list of model drugs.
7. Strengthen GI stability requirement.
A review on waiving in vivo bioequivalence tests or Biovaiwer, with a case review on the biowaiver monograph on Ibuprofen by H. POTTHAST, J.B. DRESSMAN, H.E. JUNGINGER, K.K. MIDHA, H. OESER, V.P. SHAH,
H. VOGELPOEL, D.M. BARENDS
in J Pharm Sci 94:2121–2131, 2005
Explaining different approaches to waive different BCS class medicines based on their solubility and permeability, as is described by FDA and WHO
Bioavailability & Bioequivalence ppt, Objectives, Improving bioavailability, Assessment of bioavailability, Urinary excretion studies, Blood serum studies, in vitro drug dissolution testing, need for dissolution testing, in vitro drug dissolution testing models, Bioequivalence, Therapeutic equivalence, Types of bioequivalence studies, Pharmacokinetic studies, Methods to enhance dissolution rate.
Bio pharmaceutical classification System [BCS]Sagar Savale
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
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
A review on waiving in vivo bioequivalence tests or Biovaiwer, with a case review on the biowaiver monograph on Ibuprofen by H. POTTHAST, J.B. DRESSMAN, H.E. JUNGINGER, K.K. MIDHA, H. OESER, V.P. SHAH,
H. VOGELPOEL, D.M. BARENDS
in J Pharm Sci 94:2121–2131, 2005
Explaining different approaches to waive different BCS class medicines based on their solubility and permeability, as is described by FDA and WHO
Bioavailability & Bioequivalence ppt, Objectives, Improving bioavailability, Assessment of bioavailability, Urinary excretion studies, Blood serum studies, in vitro drug dissolution testing, need for dissolution testing, in vitro drug dissolution testing models, Bioequivalence, Therapeutic equivalence, Types of bioequivalence studies, Pharmacokinetic studies, Methods to enhance dissolution rate.
Bio pharmaceutical classification System [BCS]Sagar Savale
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
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
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 STUDIES, BIOEQUIVALENCE, REASONS TO PERFORM BIOEQUIVALENCE STUDIES , NEED FOR BIOEQUIVALENCE STUDIES, IMPORTANCE OF BIOEQUIVALANCE STUDIES, DETERMINATION OF BIOEQUIVALENCE OF A DRUG PRODUCT, CLINICAL SIGNIFICANCE.
biopharmaceuticals classification system and biowaiverRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
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.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
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5. Equivilence
It is a relative term that compares drug products with
respect to a specific characteristic or function or to a
defined set of standards
Definition
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Chemical equivalence
It indicates that two or more drug
products contain the same
labelled chemical substance as
an active ingredient in the
same amount.
+
Definition
8. ‘
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The FDA (USP DIB Volume III) defines the term as:
Drug products are considered pharmaceutical
equivalents if they contain the same active
ingredient(s), are of the same dosage form, route of
administration and are identical in strength or
concentration (for example chlordiazepoxide
hydrochloride, 5 mg capsules)
(USP DIB Volume III)
Pharmaceutical equivalent
Pharmaceutical equivalent product
Possible differences
Excipients, drug particle size,
manufacturing site, equipment, batch size
etc.
Reference
product
Test
product
Definition
9. Pharmaceutical Equivalents
Test Reference
Possible Differences
Drug particle size
Excipients
Manufacturing
Equipment or
Process
Site of
manufacture
Could lead to differences in product performance
in vivo
Possible Bioinequivalence
10. ‘
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Bioequivalent
The rate and extent of absorption of the test drug
do not show a significant difference from the
rate and extent of absorption of the reference
drug when administered at the same molar
dose of the therapeutic ingredient under
similar experimental conditions in either a
single dose or multiple doses.
(USP DI® Volume III):
Definition
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Therapeutic
equivalent
The FDA classifies as
therapeutically equivalent those
products that meet the following
general criteria:
This term indicates that two or more drug
products that contain the same
therapeutically active ingredient elicit
identical pharmacological effects and can
control the disease to the same extent.
+
Definition
12. ‘
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Biopharmaceutical
classification system
BCS
The BCS is a scientific framework for classifying
drug substances based on their aqueous
solubility and intestinal permeability. When
combined with the dissolution of the drug
product, the BCS takes into account three major
factors that govern the rate and extent of drug
absorption from IR solid oral dosage forms.
Definitions
14. ‘
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Drug
bioavailability
Bioavailability refers to the extent and
rate at which the active moiety (drug
or metabolite) enters systemic
circulation, thereby accessing the site
of action
Definitions
16. Path of drug: From tablet
to blood
(Bioavailability)
• Drug move from oral cavity direct into
blood(sublingual tablets) or move to
stomach
• In stomach drug will disintegrate and then
move towards small intestine having basic
pH
• In small intestine, the drug will absorb and
move towards liver by HPV and then
become the part of systemic circulation
17. Scheme of Oral Dosage Form
Oral Bioavailability(%F)
Human Intestinal
Absorption(HIA)
1,2 – Stability + Solubility 3
– Passive + Active Tr.
4 – Pgp efflux + CYP 3A4
18. Purpose of Bioavailability Studies
• To ensure safety of the drug
• To ensure efficacy of the drug
• To establish recommended dosage regimen.
• To define the effect of changes in the physicochemical properties of
the drug substance, the formulation of the drug, and the
manufacture process of the drug product (dosage form).
• To establish the effect of food on the pharmacokinetics of drugs.
• To provide indirect information regarding the presystemic and
systemic metabolism and the role of drug transporters
19. WHEN BIOAVAILABILITY AND
BIOEQUIVALENCE TESTING IS ESSENTIAL?
For new indication
For new dosage regimen or dosage
strength
For new formulations
A
B
C
For new dosage form
For new salt or ester of a drug.
For all new molecules
A
B
C
For a change in the manufacturing
process of the drug or drug product.
C
For administration in special
population, e.g. pediatrics
C
20. 06
01
02
03
04
05
To evaluate absolute
bioavailability of dosage
form compared to with
reference dosage form
To determine if equipotent drug
treatments administered at
different dose strength of the
market form produce equiva ent
drug bioavailability,
To determine if
bioavailability parameters
are linear over proposed
dosage range
Intervention study to
examine effect of food
and other factors
Inter/intra subject
variability
Bioequivalence stucy
reeded as a result of
changes in theformulation
or manufacturing
processes.
Importance of bioequivalence study
21. Important for post-
approval changes in the
marketed drug
formulation
Important for linking the
commercial drug product
to clinical trial material at
time of NDA
Establish that the new
formulation has
therapeutic equivalence
in the rate and extent of
absorption to the
reference drug product
Goals of bioequivalence
22. Plasma drug
concentration
Urinary drug excretion
In vivo pharmacodynamic (PD)
comparison
Clinical endpoint study
In vitro binding studies
IN VIVO MEASUREMENT OF
ACTIVE MOIETY OR MOIETIES
IN BIOLOGICAL FLUIDS
03
02
01
04
05
23. 1- PLASMA DRUG CONCENTRATION
The most direct and objective
way to determine systemic drug
bioavailability.
27. Parameters
2- URINE DRUG EXCRETION DATA
• Urinary drug excretion data is
an indirect method for
estimating bioavailability. The
drug must be excreted in
significant quantities as
unchanged drug in the urine.
Cumulative amount of
drug excreted in the
urine (Du)
Rate of drug
excretion in the
urine (dDu/dt)
Time for maximum
urinary excretion (t)
2
1 3
28. 3-
In
vivo
pharmacodynamic
comparison • If the quantitative measurement of a drug in plasma is not
available or in vitro approaches are not applicable, then
pharmacodynamic (PD) effects are monitored. A dose-
response relationship is demonstrated.
• Sufficient measurements should be taken to assure an
appropriate PD response profile
30. 4 This approach may be
considered acceptable only
when analytical methods
cannot be developed to permit
use of one of the other
approaches
2- The FDA considers this approach
only when analytical methods and
pharmacodynamic methods are not
available to permit use of one of the
approaches described above
3- recommended for
those products that have
negligible systemic
uptake
1- the least accurate, least
sensitive to
bioavailability
differences, and most
variable
4- Clinical endpoint study
31. Option 3
Option 4
Option 1
Option 2
4- For drugs whose dissolution rate
is related to the rate of systemic
absorption, the test formulation that
demonstrates the most rapid rate of
drug dissolution in vitro will
generally have the most rapid rate of
drug bioavailability in vivo.
3- Comparative dissolution
profiles may be considered
similar if the similarity factor
(f2) is greater than 50..
2- Ideally, the in vitro drug dissolution rate
should correlate with in vivo drug
bioavailability (in vivo-in vitro correlation,
IVIVC).
1- Comparative drug
release/dissolution studies under
certain conditions may give an
indication of drug bioavailability
and bioequivalence
5- IN VITRO STUDIES
32. LOREM IPSUM
Potential Situations where an In Vitro BE
Determination May be of Use
Generic drug
applications
1
When the innovator
wishes modify an
existing formulation
2
When BE needs to be
determined for a
combination drug product
where one component is
systemically absorbed and
the other is a locally acting
compound
3
33. IVIVC is the predictive, mathematical models
relating an in-vitro property such as
dissolution and an in-vivo response, e.g.,
amount of drug absorbed, thus allowing an
evaluation of the QC specifications, change
in process, site, formulation and application
for a biowaiver etc. –
US FDA
IVIVC
35. Dissolution profile comparison
The test and reference products for
which in vitro release rates form
the basis of the bioequivalence
usually demonstrate Q1/Q2
sameness (qualitatively same
inactive ingredients in the
quantitative same amounts).
Comparative
dissolution studies
are often performed
on several test
formulations of the
same drug during
drug development.
Comparative dissolution
profiles may be
considered similar if
the similarity factor
(f) is greater than 50
1 2 3
36.
37. 1 2
To Develop in-vitro in-
vivo correlation which
can help to reduce
costs, speed-up
product development
and reduce the need
to perform costly
bioavailability human
volunteer studies
Establish the similarity of
pharmaceutical dosage
forms, for which
composition, manufacture
site, scale of manufacture,
manufacture process and/or
equipment may have
changed within defined
limits
Objective of dissolution profile Comparison
38. Example
For the acyclovir topical ointment, recommended
BE approaches consist of comparative in vitro
release testing and physicochemical
characterization
(US-FDA, CDER, 2012b).
Any other approach deemed acceptable (by the FDA)
• The FDA may also use in vitro
approaches other than comparative
dissolution for establishing
bioequivalence.
• The FDA accepts various other in
vitro approaches for BE
assessment of proposed generic
locally acting drug products.
40. The nature of the
reference material and
the dosage form to be
tested
The availability of
analytical methods
The route of drug
administration
The pharmacokinetics
and pharmacodynamics
of the drug substance
The scientific questions
and objectives to be
answered
Benefit-risk and ethical
considerations with
regard to testing in
humans.
01
02
03
04
05
06
BE Study
considerations
42. 1- Analytical methood
2- Pharmacokinetic
evaluation of data
3- Statistical evaluation of data
4- Analysis of variance
Evaluation of bioequivalence studies
45. 1-Crossover study design
1. Complete crossover design is usually employed, in which each subject receives
the test drug product and the reference product.
2. In this design, each subject is his own control, and subject-to-subject variation is
reduced.
3. The order in which the drug treatments are given should not stay the same in
order to prevent any bias in the data due to a residual effect from the previous
treatment.
4. In two-period study is a study that is performed on two different days (time
periods) separated by a washout period during which most of the drug is
eliminated from the body-generally about 10 elimination half-lives.
47. 2- Replicated crossover study design
1. The standard bioequivalence
criterion using the two-way crossover
design does not give an estimate of
within-subject
(intrasubject)variability.
2. By giving the same drug product
twice to the same subject, the
replicate design provides a measure
for within-subject variability•
Replicate design studies may be used
for highly variable drugs and for
narrow therapeutic index drugs.
3. Replicated crossover designs are used
for the determination of individual
bioequivalence, to estimate within-
subject variance for both the test and
reference drug products, and to
provide an estimate of the subject by
formulation interaction variance.
49. 3- Parallel study design
1. Multiple doses of the
same drug are given
consecutively to reach
steady-state plasma. In
this design, two separate
groups of volunteers are
used. One group will be
given the test product
and the other group will
be given the reference
product.
2. multiple-dose study is
designed as a steady-
state, randomized, two-
treatment, two-way,
crossover study
comparing equal doses
of the test and reference
products in healthy
adult subjects.
3. The area under the
curve during a dosing
interval at steady state
should be the same as
the area under the curve
extrapolated to infinite
time after a single dose.
51. 4- Multiple dose study design
1. A non-replicate, parallel depot
injections in which the drug is slowly
released over weeks or months design
is used for drug products that contain
drugs that have a long elimination
half-life or drug products such as
2. In this design, two separate groups of
volunteers are used. One group will
be given the test product and the
other group will be given the
reference product.
3. Blood sample collection time should
be adequate to ensure completion of
gastrointestinal transit
(approximately 2-3 days) of the drug
product and absorption of the drug
substance.
4. This design is not recommended for
drugs that have high intrasubject
variability in distribution and
clearance.
52. AUC Cmax Cav
tmax Cmin
Degree of
fluctuation
PK analyses for multiple for multiple dose structured
studies includes calculation of following parameters for
each subject
53. Biowaivers
In some cases, in vitro dissolution testing may be used in
lieu of in vivo bioequivalence studies. When the drug
product is in the same dosage form but in different
strengths and is proportionally similar in active and
inactive ingredients, an in vivo bioequivalence study of
one or more of the lower strengths can be waived bases
on dissolution testing and an in vivo bioequivalence
study on highest strength.
54. An acceptable BE study is
conducted on at least one
strength.
.The strength(s) for which
the biowaiver sought should
be proportionally similar to
the strength on which BE
wasdemonstrated.
Acceptable in vitro
dissolution should be
demonstrated for the
strength(s) for which the
biowaiver is sought.
01 02 03
Regulatory perspective for biowaivers
55. appropriate in vitro
dissolution data should
confirm the adequacy of
waiving additional in vivo
bioequivalence testing
qualitative composition
of the different strengths
is the same
composition of the
strengths are quantitatively
proportional,
Products are manufactured
by the same manufacturing
process
General requirements must be met where a
waiver for additional strength(s) is claimed
58. ‘
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Patent
• Protects the investment of the drug
company that developed the brand-
name drug
• Gives the drug company the sole right
to sell the drug while the patent is in
effect
Definition
59. ‘
When the patent on a brand-name drug
nears expiration, drug companies that want
to manufacture a generic can apply to FDA
to sell a generic version of the drug
Patent protection
60.
61. CREDITS: This presentation template was created by
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Thanks!
Do you have any questions?
62. ● Leon Shargel; Andrew B.C Yu, Applied
Bio pharmaceutics ar
pharmacokinetics, Fourth edition,pp
256-271.•
● D.M.Brahmankar, Sunil b. jaiswal,
Biopharmaceutics and
Pharmacokinetics, A Treatise, second
edition, vallabh prakashan,pp336-344..
References