Pharmacokinetics Module

The definitive source of data from regulatory documents

FDA, EMA and AERS documents contain vast amounts of crucial data that never reach academic publications.

The Pharmacokinetic Module allows you to search these data, which have been extracted from more than 1.6 million pages, including FDA Approval Packages (1992 to present) and EMEA EPARs (1995 to present). The inclusion of historical FDA documentation dating back to 1938 means that this module gives you complete historical coverage as well as opening up the cutting edge of drug approval data.

Crucial Information Revealed

Consolidated access to data you won’t easily find elsewhere

The Pharmacokinetics Module grants access to a range of information that is not otherwise easy to find. Data are extracted from EMA EPAR documents and FDA Approval Packages and presented in context so that you can quickly see everything you need. This includes detailed exposure data (Cmax, Tmax, T1/2, AUC, etc.) that are almost never published and are not available via any other commercial research and critical data on drug efficacy, indications and dosage, safety, pharmacokinetics studies, mode of action, and adverse effects. Maximize your access with the Pharmacokinetics Module.

Broad Coverage and Perfect Focus

Key data extracted from relevant documents on a huge range of substances

The Pharmacokinetics Module extracts the most relevant information from a broad range of sources, including approximately 100,000 pages of searchable EPAR documents on EMA-approved drugs. Furthermore, it includes metabolite data, target information, and preclinical and clinical toxicity data from a pool of over 3,000 journals and other global sources. To give an even broader overview of this critical aspect of drug development, the Pharmacokinetics Module also contains Meyler’s definitive work Side Effects of Drugs (15th edition), which has over 40,000 references of interest.

Insight on a Global Scale

One platform with unparalleled access to both FDA and EMA documents

With the possibility to compare data extracted from 1.6 million pages of regulatory documentation, the Pharmacokinetics Module helps you to gain real insight into the differences between the FDA and EMA decision-making processes. For example, the database contains information about over 50 drugs and active ingredients approved in Europe but not in the US. See the differences, improve your own regulatory submissions, and benefit from competitive advantages on the global market.

Intelligent Search Functions

Search terms and filters that give you more refined searching power

The Pharmacokinetics Module is an indispensable tool for pharmacokinetics analysis. It is designed to give you the possibility to refine your search results and highlight what is most important to your research. You can search for key parameters and experimental conditions and apply filters to refine the results. You also have the option to sort your results under multiple conditions. These include:

Drug name
Concomitant drugs
Dose or standard dosage
Route
Value (normalized in searching)
Disease states
Demographic differences
Species
Study group (population)
Enantiomers
Metabolites

The Pharmacokinetics Module is an indispensable tool for pharmacokinetics analysis. It is designed to give you the possibility to refine your search results and highlight what is most important to your research. You can search for key parameters and experimental conditions and apply filters to refine the results. You also have the option to sort your results under multiple conditions. These include dose, route, disease states, demographic differences, and metabolites.

Historical Context

Searchable documents dating back to 1938 in the “FDA Classic Collection”

Older FDA documents can give you an edge in the approval process and open up repurposing opportunities for older drugs. The Pharmacokinetics Module allows you to explore the whole history of drug development data in a single search. Search efficacy, safety, and pharmacokinetics information from the FDA FOI archives dating back to 1938, and look at the available biology and chemistry data on older drugs to find new modeling data sets and repurposing opportunities. Many more recent documents cite documents from pre-1992; every citation of a previous FDA document is now traceable, searchable and viewable with the Pharmacokinetics Module

Versatility in Drug Discovery

The possibilities are endless

The Pharmacokinetics Module is a highly versatile tool. Use it to model therapeutic windows for new drug projects earlier and more effectively than ever before. You can also model the effects of different chemical substructures or active groups on exposure properties. It allows you to compare internally generated exposure data with drugs that share similarities in terms of their class, chemistry and targets. Crucial risk assessments are also possible, so you can answer key questions, such as “Can this drug be properly delivered at a safe dose?” The Pharmacokinetics Module can do all this and more for you. Discover the benefits today!

Online tools & resources