Find out about the Pharmacokinetics Module
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Transcript of Find out about the Pharmacokinetics Module
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
“ Show me all the food effect data for drugs in my class with a T1/2 over 5 hours.” Search example
Better inform your decision-making when prioritizing and directing candidates for development.
Gain competitive advantages: e.g. find out how to deliver a drug better than your competitors, learn where the bar has been set and identify competitive opportunities for any drug class based on your proprietary delivery methods or formulations.
With access to this wealth of data, you can:
Create modeling sets: e.g. model therapeutic windows on new drug projects earlier and more effectively than ever before and model the effects of different chemical substructures or active groups on exposure properties.
Make drug development project risk assessments: e.g. can this drug be properly delivered at a safe dose?
Understand potential pharmacokinetic responses: e.g. food effects, concomitant drugs, co-morbidities and demographic effects.
Compare internally generated exposure data with drugs sharing similarities in class, chemistry or targets.
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 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 pharmacokinetic, preclinical and clinical exposure, and drug-safety data searchable and filterable in one platform.
Extracted data from more than 1.5 million pages, from:
FDA Approval Packages (1992 to present)
FDA Classic Collection (1938 to 1991)
EMEA EPARS (1995 to present)
All of these PK parameters can be searched, filtered, or sorted under multiple experimental conditions, for example:
Drug name
Concomitant drugs
Dose
Route
Value (normalized in searching)
Standard dose
Disease states
Demographic differences
Species
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 answerWe 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.
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