This document summarizes a presentation on structuring the submission of abuse deterrence data and formulating the abuse-deterrent formulation (ADF) label. It discusses:
1) The FDA's recent announcement requiring safety labeling changes and post-marketing studies for extended-release/long-acting opioids regarding risks of misuse, abuse, addiction, overdose and death.
2) The FDA's draft guidance outlining four tiers of potential labeling claims for ADFs based on whether products can be expected to or actually do reduce abuse potential.
3) Examples are provided of what categories of preclinical and clinical data may support each tier of claim, with precedent currently set at a Tier III claim for
This presentation is aimed at presenting the issues associated with subgroup analyses in clinical trials: the different types of subgroup analyses and the statistical issues associated with the conduct of subgroup analyses.
This presentation is aimed at presenting the issues associated with subgroup analyses in clinical trials: the different types of subgroup analyses and the statistical issues associated with the conduct of subgroup analyses.
Meta Analysis of Medical Device Data Applications for Designing Studies and R...NAMSA
Meta Analysis of Medical Device Data Applications for Designing Studies and Reinforcing Clinical Evidence discusses what meta analysis is as well as the potential benefits.
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
An overview of the ICH E9 guidance. Easy to follow, and I can provide a live presentation of this to your team! Great for those who are not familiar with statistics.
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Miklos Schulz
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Clinical Trial Registries: Panacea or Pablum?Michael Swit
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
Meta Analysis of Medical Device Data Applications for Designing Studies and R...NAMSA
Meta Analysis of Medical Device Data Applications for Designing Studies and Reinforcing Clinical Evidence discusses what meta analysis is as well as the potential benefits.
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
An overview of the ICH E9 guidance. Easy to follow, and I can provide a live presentation of this to your team! Great for those who are not familiar with statistics.
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Miklos Schulz
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Clinical Trial Registries: Panacea or Pablum?Michael Swit
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
Clinical Trial Registries & Databases: An UpdateMichael Swit
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
SDTM Training for personnel with Junior and Intermediate level Clinical Trial Experience. Covers summary of most domains. Salient features include order of domain creation, importance of making programming Data/Metadata Driven, Nature of Clinical Raw Data, Summary of the Clinical Trial process with regards to the data flow to arrive at the Study data to be submitted to regulatory authorities like FDA, Importance of deriving ADAM from SDTM and not directly from raw data, Information has been put together from variety of sources including my own programming work.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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.
Stay informed, stay safe, and get your flu shot today!
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Surgical Site Infections, pathophysiology, and prevention.pptx
Structuring the Submission of Abuse Deterrence Data and Formulating the ADF Label
1. Structuring
the
Submission
of
Abuse
Deterrence
Data
and
Formula7ng
the
ADF
Label
Naama
Levy-‐Cooperman,
PhD
Director
and
Principal
Altreos
Research
Partners
Inc.
INC
Consultant
ADF
Scien7fic
Mee7ng
October
30
–
September
1,
2013
Bethesda,
MD
3. Outline
• Introduc7on
• Brief
summary
of
FDA
announcement
– Safety
labeling
changes
&
post-‐marke7ng
study
requirements
for
ER/LA
opioids
• Labeling
– Background
– Tier
I
to
Tier
IV
• Structure
of
Tier-‐Analysis
4. FDA
ER/LA
Labeling
and
Post-‐
Marke7ng
Requirements
•
September
10,
2013
–
FDA
releases
class-‐wide
safety
labeling
changes
and
new
post-‐market
study
requirements
for
all
ER/LA
opioid
analgesics
– Safety
labeling
changes
• Indica7on
changes:
Old:
indicated
for
the
management
of
moderate
to
severe
pain
when
con7nuous,
around-‐the-‐
clock
analgesic
is
needed
for
an
extended
period
of
7me.
New:
For
pain
severe
enough
to
require
daily,
around
the
clock,
long-‐
term
opioid
treatment
and
for
which
alterna3ve
treatments
are
ineffec3ve,
not
tolerated,
or
otherwise
inadequate
to
provide
sufficient
management
of
pain.
…not
indicated
as
an
needed
analgesic
–
Post-‐marke3ng
• Conduct
one
or
more
studies
to
provide
quan7ta7ve
es7mates
of
the
serious
risks
of
misuse,
abuse,
addic7on,
overdose,
and
death
• ………only
a
clinical
trial
(rather
than
a
nonclinical
or
observa7onal
study)
will
be
sufficient
to
assess
the
known
serious
risk
of
hyperalgesia
…..
5. Required
Post-‐marke7ng
Studies
2065-‐3
Validate
coded
medical
terminologies
used
to
iden7fy
misuse,
abuse,
overdose,
death
2065-‐2
Develop
AND
validate
measures
of
misuse,
abuse,
overdose,
death
2065-‐4
Define
and
validate
“doctor/pharmacy
shopping”
as
outcome
2065-‐1
Quan7ta7ve
es7mates
of
the
serious
risks
of
misuse,
abuse,
overdose,
death,
hyperalgesia
2065-‐5
Es7mate
risk
of
hyperalgesia
following
ER/LA
6. Introduc7on
• ADF
Draa
Guidance:
“When
the
data
predict
or
show
that
a
product’s
poten2ally
abuse-‐deterrent
proper2es
can
be
expected
to,
or
actually
do,
result
in
a
significant
reduc2on
in
that
product’s
abuse
poten2al,
these
data,
together
with
an
accurate
characteriza2on
of
what
the
data
mean,
should
be
included
in
product
labeling.”
7. Four
Tiers
of
Labeling
Claims
Actually
do
IV
III
Can
be
expected
to
II
I
• Demonstrated
reduced
abuse
in
the
community
• Expected
to
result
in
meaningful
reduc7on
in
abuse
• Expected
to
reduce
or
block
effect
of
the
opioid
when
the
product
is
manipulated
• Formulated
with
physiochemical
barriers
to
abuse
8. Labeling
• For ADFs, label is more important than scheduling
– Primary interface with prescribers, patient community, and public
– Safety & indication
– Can allow market distinction
– Risk management tool
• Requirements for and example “explicit claims” outlined in guidance
(Tier I to IV claims)
• Statements summarizing preclinical or clinical data can be included
within label
– Category 1 to 3 data summaries within label
• Labels can be modified post-approval with appropriate supporting
data
9. Labeling
• Guidance
suggests
that
data
from
all
3
categories
of
study
are
expected
for
any
of
the
the
first
3
7ers
• No
guidance
on
magnitude
of
effect
sufficient
to
support
each
type
of
claim
• To
date,
Tier
I
and
Tier
II
claims
have
not
made
it
into
a
label
– OxyCon7n®
–
Tier
III
Sec7on
9.2
– Embeda®
-‐
Implicit
claim,
sec7on
12
(Clinical
Pharmacology)
– Oxecta®
-‐
Implicit
claim,
Sec7on
9.2
10. Example:
Tier
I
Claim
• Product
with
physiochemical
barrier
to
abuse
Category
1
Category
1
Tier
I
Category
3
Tier
I
or
Tier
III
• According
to
guidance,
data
from
Category
1
not
sufficient
for
any
claim
• Category
2
only
relevant
if
tampering
with
product
(crushed
etc.)
results
in
complete
maintenance
of
ER
proper7es,
since
no
blocking
or
reduc7on
11. Example:
Tier
II
Label
• Combina7on
agonist/antagonist
product
Category
2
Category
1
Category
1
Category
2
OR
Tier
II
Category
3
Tier
II
or
Tier
III
12. Example:
Tier
I/II
Label
• Prodrug
Category
1
Category
2
Tier
I
and/or
II
• Category
3
data
not
necessary
if
product
is
not
ac7ve
un7l
metabolized
in
GI
tract
aaer
oral
inges7on
13. OxyCon7n®
• Purdue
Pharma
conducted
the
following
studies:
– In
vitro
tests
(Category
1)
– PK
&
PD
studies
(Category
2
&
3)
– Epidemiological
studies
(Category
4)
• Precedent
set:
only
achieved
Tier
III
label
• Possibility
of
Tier
IV
following
comple7on
of
long-‐term
post-‐marke7ng
studies?
14. Can
Tier
III
claim
be
achieved
by
other
opioid
ADFs?
• Need
“meaningful
reduc7on”
• What
is
meaningful
in
terms
of
“drug
liking”
scores
(i.e.,
the
ever-‐elusive
CID?)
• Op7ons:
– Non-‐inferiority
approach-‐
“at
least
not
worse
than”
– OxyCon7n®
as
the
ac7ve
comparator
in
abuse
liability
study?
15. Where
does
a
Tier
IV
claim
fit
in?
• OxyCon7n®
unique
situa7on
-‐
epidemiological
data
was
collected
and
submiked…Tier
III
label
claim
• “The
postmarke7ng
data
support
the
conclusions
reached
using
the
in
vitro,
PK,
and
clinical
data,
but
do
not
yet
demonstrate,
a
reduc3on
in
OCR
abuse
following
replacement
of
OC
with
OCR
in
the
marketplace.”
(Office
Director
Memo
Abuse
-‐
Deterrent
Proper7es
of
Purdue’s
Reformulated
OxyCon7n
[oxycodone
hydrochloride]
Extended-‐Release
Tablets)
• Post
marke7ng
epidemiologic
studies
of
single
products
for
the
purpose
of
a
Tier
4
label
are
scien7fically
very
problema7c
• Is
the
7er
IV
claim
possible
for
other
products?
16. Label
Development
• Factual, based on supporting evidence
“This
informa7on
should
be
communicated
as
clearly
and
transparently
as
possible.”
“Must
contain
a
summary
of
the
essen7al
scien7fic
informa7on
needed
for
the
safe
and
effec7ve
use
of
the
drug.”
“…accurate
characteriza7on
of
what
the
data
mean.”
• Tier
labeling
examples
are
clear
as
outlined
in
guidance
• Are
the
summary
of
studies
providing
the
best
informa7on?
– Summarize
study
data
vs
road
map
to
abuse
– Can
the
audience
interpret
the
data?
17. Which
is
easier
to
interpret?
Responder
Analysis
Data
VS.
Time
Course
Data
Setnik
et
al.,
2013.
18. Tier
Analysis
-‐
Regulatory
Submission
• Abbreviated
evalua7on
Tier
Analysis
• Approach
acceptable
for
known
en77es
(i.e.,
drugs
with
substan7ally
similar
pharmacology
to
marketed
products
or
reformula7on
of
marketed
product)
• Expec7ng
same
schedule
• Pro-‐drugs
/
NCEs
•
•
8-‐factor
analysis
to
build
argument
for
differen7al
scheduling
E.g.,
NKTR-‐181:
New
Mu
Opioid
Analgesic
Molecule
for
Chronic
Pain
Intended
to
Deter
Abuse
and
Reduce
CNS
Side
Effects
by
Reducing
the
Rate
and
Extent
of
Entry
into
the
CNS
(Webster
et
al.,
Poster
presented
at
CPDD
2013)
19. Elements
of
Tier
Analysis
Laboratory-‐based
In
Vitro
Manipula7on
and
Extrac7on
Studies
(Category
1)
• Can
include
pre-‐clinical
data
(if
relevant)
Pharmacokine7c
Studies
(Category
2)
Clinical
Abuse
Poten7al
Studies
(Category
3)
• Summary
of
clinical
trial
abuse-‐related
AEs
(if
relevant)
Post-‐marke7ng
Studies
(Category
4)
Summary
Proposed
labeling
language
20. Summary
• Tiered
labeling
approach
provides
clear
guidelines
on
the
4
categories
of
study
required
to
support
claims
• Some
ambiguity
on
whether
certain
7ers
can
be
achieved
(i.e.,
Tier
III
and
IV)
– Could
approved
ADFs
be
added
as
comparators
in
HAL
studies?
• To
date
studies
including
Category
1,
2
and
3
data
of
tampered
ADF
products
have
been
consistent
with
post-‐
marke7ng
expecta7ons
(N=1)
• Un7l
addi7onal
products
approved,
only
standard
is
OxyCon7n®
• Informa7on
(including
data)
included
in
the
label
should
be
interpretable
by
end
user