PharmaPendium

www.info.pharmapendium.com
Please contact us
for more information
Americas
E-Customer Service
360 Park Avenue South
New York, NY 10010-1710 USA
Tel: +1 888 615 4500
(+1 212 462 1978, if calling from outside the USA
and Canada)
Fax: +1 212 462 1974
Email: [email protected]
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E-Customer Service
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60486 Frankfurt/Main, Germany
Tel: +49 69 5050 4268
Fax: +49 69 5050 4213
Email: [email protected]
Asia Pacific
E-Customer Service
1-9-15 Higashi-Azabu
Minato-ku, Tokyo 106-0044 Japan
Tel: +81 3 5561 5034
Fax: +81 3 5561 5047
Email: [email protected]
The definitive source of integrated preclinical,
clinical and post-marketing drug information for:
PharmaPendium
The definitive source of
best-in-class drug information
Preclinical and Clinical Safety Assessment
Toxicology, Adverse Events
Delivery
Pharmacokinetics, Exposure Data
• Save time and operational costs
• Gain actionable data
• Plan intelligently
• Act smartly
Efficacy
Biomarkers, Experimental Design, Primary & Secondary Endpoints
Regulatory Affairs
Precedents from Entire Library of FDA Approval Documents
PharmaPendium is a trademark of Elsevier Inc. RTECS is a registered trademark of the U.S. Public Health Service in the United States.
MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers Associations in the United States.
Separate license to MedDRA required. All other names are or may be trademarks or registered trademarks of their respective owners.
*Separate license to MedDRA required.
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Insightful Content Plus
Powerful Functionality
Now you can search, view and compare documents from the
world’s two major regulatory agencies – the FDA & EMEA
– at the same time, on a single site, with a single search.
PharmaPendium enables pharmaceutical researchers in preclinical
and clinical drug development to finally be able to...
Save valuable time
Reduce strategic or opportunity costs
PharmaPendium saves weeks to
months typically spent during the
drug development process on finding
drug safety and approval data
through document delivery services
or the FDA.
PharmaPendium gives you a clear strategic advantage by providing new
(mostly unpublished) relevant comparative data before making a decision
or assessment.
• Avoid the submission mistakes made by competitors: Eliminate the risk
of repeating costly regulatory cycles by searching historic FDA approval
documents for previously unacceptable submissions. Save the cost of
re-submission and the opportunity cost on your patent.
• Compare preclinical and clinical safety data of approved drugs to better
predict animal model to human translation from the toxicity/adverse
effect perspective.
• Reduce drug development cost by identifying safety risks earlier.
• Learn from approved drugs by viewing their integrated post-marketing
safety data with toxicity/adverse effect data obtained in preclinical and
clinical studies.
PharmaPendium provides
searchable access to more than
850,000 pages of safety
information in seconds… so there
is no need to spend weeks reading
and skimming to find comparable
data for safety profiles (animal,
human and post-marketing data) for
drugs similar to your candidate.
www.info.pharmapendium.com
Avoid re-inventing
the wheel
Using the globally-searchable
PharmaPendium, researchers can
find and cite previously run
preclinical experiments they did
not know even existed, possibly
eliminating the need for planned
studies that would have taken years
to accomplish.
PharmaPendium meets the critical needs of a
variety of users within the biopharmaceutical
industry including:
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Preclinical Safety Assessment Teams
Toxicologists
Pharmacokineticists
Safety Pharmacologists
Regulatory Affairs Staff
Pharmacoepidemiologists
Clinical Researchers
Information Specialists
Leverage the best
historic data in a
meaningful way
Prevent repeating
the mistakes of
the past
Respond quickly
under pressure (the
urgency factor)
PharmaPendium makes the
entire FDA library of Freedom
of Information (FOI) documents
on the approval of drugs and their
efficacy, safety, pharmacokinetics
and pharmacodynamics detailed
experimental data searchable and
accessible for the first time.
PharmaPendium is the best tool
available to avoid “Regulatory
Recycling” by carefully examining
data, statistics and experimental
designs that were rejected in the past
within your Drug Class or by
your Reviewer.
Have searchable documents at your
fingertips in minutes when, for
example, you are responding to FDA
inquiries. When your patent clock is
ticking, response time and fast
access to precedents are critical.
the only integrated and text-searchable source of FDA
(back to first approved drug) and EMEA documents
Pharmacokinetics
Researchers: Make
sure you have the
Complete Picture
PharmaPendium contains volumes
of preclinical AND clinical
exposure data at all parameters
(cmax, tmax, AUC,Vss, CL, etc.) and
all study groups (Healthy, Disease
state, Concomitant Drugs) – the vast
majority of which are not published
in the literature and so available
nowhere else. This level of detail now
available to drug delivery experts as a
means of comparison or to draw
inferences is a true breakthrough.
Best-in-Class, Trusted
Content Sources
Extracted data sets and the
only product to provide
longitudinal data views
PharmaPendium provides access via a single point to
searchable and trusted drug safety information covering over
3,000 approved drugs, with integrated preclinical, clinical and
post-marketing safety data.
• US FDA Drug Approval Package Database (Reviews: post 1991)
Sophisticated functionality saves you time
• New! FDA Classic Collection – all FDA drug approval documents on all drugs from
1992 back to the first approval files
PharmaPendium users have discovered that tasks that
used to take several people weeks – or even months – are
now easily done in minutes.
The combination of these two databases creates an entire searchable library
of documents written by the FDA on the approval of drugs,
pharmacokinetics, efficacy and safety
• New! European Medicines Agency (EMEA) European Public Assessment Reports
(EPAR) Approval Documents Database (Drugs or indications approved in Europe
with manually extracted preclinical, clinical toxicity and adverse effects data –
contains drugs not approved in the US)
Customizable searching yields results that help you
make the right decisions
Intuitive user interface with searchable access to all content
Usability and Efficiency
That Simplify Research
• Meyler’s Side Effects of Drugs, 15th edition
• Adverse Event Reporting System (AERS) Database
• Target information and target-drug relationships from multiple sources
PharmaPendium is designed to help you develop safer drugs with
increased efficiency, reduced risks and lowered cost.
• The PharmaPendium Drug Safety Database -- Pre-clinical and clinical toxicity data
manually extracted from all FDA Approval Packages
• Toxicity information for approved drugs extracted from literature
• Metabolite and metabolic transformation information for PharmaPendium drugs
extracted from literature
Dynamic interface streamlines the
research process
Searchable FDA Drug Approval Document
www.info.pharmapendium.com
Previously FDA Freedom of Information
documents and EMEA EPARs were only
available in unsearchable formats like
microfiche (order paper copy from FDA
FOI), paper or a static PDF containing an
unsearchable image.
Now PharmaPendium finally solves this
problem by delivering fully searchable,
electronic FDA and EMEA documents.
All FDA and EMEA documents on
PharmaPendium are globally searchable
and filterable by:
• Effect
• Targets
• Drugs
Perhaps even more importantly, PharmaPendium allows
such research and searches to find key decision-support
information that would previously have been missed.
Preclinical and clinical assessments and prioritization
can now be done with the full complement of
comparable data.
Our features enable you to:
• Conduct research using four pathway options: drug
class, adverse effects/toxicity, targets, and chemical
compound
• Search using standardized terminology—Medical
Dictionary for Regulatory Activities (MedDRA®*)
• Search text by keyword
• Filter search results by drugs/drug classes, adverse
effects/toxicity, data sources, and/or other criteria
• Search by molecular structure or substructure and
export results
• Drug Classes
• Gain searchable access to relevant sections within an
FDA package by document type
• Chemistry
• Export valuable safety information
Preclinical/Clinical
Development Assessment
Challenge
“Which competitors’ drugs have the same combination
of adverse effects as my drug candidate? Show me the
relevant preclinical and clinical studies.”
www.info.pharmapendium.com
Solution
Show all antipsychotics that have exhibited
Electrocardiogram (ECG) anomalies in preclinical
experiments, clinical trials or post-marketing reports.
Pharmacokinetics/Drug
Delivery Assessment
Challenge
“Find preclinical and clinical pharmacokinetics
exposure parameters for the drugs in my drug class
(Cmax, Tmax,Vss, etc.).”
Solution
See screenshot below.
Regulatory Affairs
Challenge
“What can I learn from the history of regulatory
cycling within my drug class in order to make this
New Drug Application (NDA) proceed more
quickly to approval?”
www.info.pharmapendium.com
Solution
Searching on “DNDP’s requests” (Division of
Neuropharmacological Drug Products).
Clinical Development
Challenge
“What are the primary and secondary endpoints that
have been described, used and approved within my
drug class?”
Solution
See screenshot below.
Timely, trusted content combined with
powerful functionality
Stay on the safe side
• The only searchable database of ALL FDA Drug
Approval Packages
• Reduce the drag of non-returning investments
• Important content beyond FDA documents – now including
EMEA “EPAR” Approval Documents
• Identify safety risks earlier
• Make better predictions on animal model to human
translation
• Use toxicity studies on excipients already reported by others
• Relevant information with an intuitive user interface and
search tools that allow researchers to identify and collect the
right information quickly
• Make the correct pipeline prioritization decisions
• Built for efficiency—data sets, data views, and other features
that enhance research productivity and yield results in minutes
rather than days
• Avoid “regulatory recycling”
• Use precedents to make the best regulatory argument as
quickly as possible
Discover the PharmaPendium advantage
at info.pharmapendium.com
• IP licensing
• Web seminars
• Interactive video demonstrations
www.info.pharmapendium.com
Visit our website today
www.info.pharmapendium.com