The new Pharmacokinetics Module provides: -unprecedented access to preclinical and clinical exposure data extracted from the entire history of FDA Approval Packages and EMEA documents -Hundreds of thousands of PK, preclinical and clinical exposure, and drug safety data searchable and filterable in one platform

1. Pharmacokinetics Module
In depth

2. What can I do with the Pharmacokinetics Module?
“Access to this new source of pharmacokinetic data will allow us to better
assess our drug projects and make more informed decisions, resulting in
better outcomes.”
Development partner
Better inform your decision-making With access to this wealth of data, you can:
when prioritizing and directing Create modeling sets: e.g. model therapeutic
candidates for development. windows on new drug projects earlier and more
effectively than ever before and model the effects
Gain competitive advantages: e.g. find of different chemical substructures or active
groups on exposure properties.
out how to deliver a drug better than
your competitors, learn where the bar Make drug development project risk assessments:
e.g. can this drug be properly delivered at a
has been set and identify competitive safe dose?
opportunities for any drug class
Understand potential pharmacokinetic
based on your proprietary delivery responses: e.g. food effects, concomitant drugs,
methods or formulations. co-morbidities and demographic effects.
Compare internally generated exposure data
with drugs sharing similarities in class, chemistry
or targets.
“Show me all the food effect data for drugs in my class with a T1/2 over 5 hours.”
Search example

3. What kind of information can I find there?
“If this has the same level of data that you have shown on thousands of drugs,
then it stands alone as a resource for pharmacokinetics data. There is no other
resource like this.”
Beta tester
The new Pharmacokinetic All of these PK parameters can be searched,
filtered, or sorted under multiple experimental
Module provides: conditions, for example:
Unprecedented access to preclinical and clinical
Drug name
exposure data extracted from the entire history of
FDA Approval Packages and EMEA documents. Concomitant drugs
Hundreds of thousands of pharmacokinetic, Dose
preclinical and clinical exposure, and drug-safety Route
data searchable and filterable in one platform.
Value (normalized in searching)
Extracted data from more than 1.5 million
Standard dose
pages, from:
Disease states
FDA Approval Packages (1992 to present)
Demographic differences
FDA Classic Collection (1938 to 1991)
Species
EMEA EPARS (1995 to present)
Study group (population)
Enantiomers
Metabolites
Tissue-specific studies

4. What does a typical search look like?
“Access to this new source of pharmacokinetic data will allow us to better
assess our drug projects and make more informed decisions, resulting in
better outcomes.”
Development partner
Find the right answer
We know that it can take great amounts of time to find all the right data, even on a single drug PK parameter.
The Pharmacokinetics Module can help you answer the kind of research questions that you deal with on a daily basis,
saving potentially months of painstaking research. The Pharmacokinetics Module helps you find all the relevant data
on your drug candidate, which means you can make better informed assessments and decisions.
Example
Can I find a drug in any class with T1/2 of more than five hours and food-effect data?
Step 1: Searching for anticonvulsants that have a T1/2 of more than five hours and filtering for
food-effect data returns from FDA Approval Packages and EMEA documents.
NB. The screen shots illustrate the beta product. The final product may differ.

5. Step 2: You can then click through from the search results to view the full study that you are interested in.
In this example, we have clicked “View Full Study” for carbamazepine.
Step 3: You can then refine your search using parameter filters, such as “species”.
NB. The screen shots illustrate the beta product. The final product may differ.

6. Technical Support/E-Customer Service Americas
Tel: +1 888 615 4500 (+1 212 462 1978, if calling from outside the USA and Canada)
Fax: +1 212 462 1974
Email: usinfo@pharmapendium.com
Europe, Middle East and Africa
Tel: +49-69-5050 4268
Fax: +49-69-5050 4213
Email: nlinfo@pharmapendium.com
Asia-Pacific
Tel: +81 3 5561 5034
Fax: +81 3 5561 5047
Email: jpinfo@pharmapendium.com
www.info.pharmapendium.com
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