Pharmacokinetics Module
In depth
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
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
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.
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.
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




               Copyright © 2010 Elsevier Properties SA. All rights reserved.
               PharmaPendiumTM trademark is owned and protected
               by Elsevier Properties SA and used under licence

Find out about the Pharmacokinetics Module

  • 1.
  • 2.
    What can Ido 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 ofinformation 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 atypical 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: Youcan 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 ServiceAmericas 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 Copyright © 2010 Elsevier Properties SA. All rights reserved. PharmaPendiumTM trademark is owned and protected by Elsevier Properties SA and used under licence