Find Safety, Efficacy and DMPK Data to Support My Analyses of in Vitro and in Vivo Test

INTRODUCTION

PharmaPendium is a decision support solution designed to improve pharmaceutical research and development by providing unique comparative preclinical, clinical andpost-release drug information in a single longitudinal database with regulatory context forFDA and EMA approvals. It answers critical questions at each stage of the drug development process.

• Find safety, efficacy and DMPK data to support my analyses of in vitro and in vivo test results?

• Compare a candidate drug to approved drugs to help optimizedrug safety analyses and trial design?

• Assess PK parameters and potential drugdruginteraction risks for my drug candidate?

• Get support for making acase to the regulatory authorities?

FEATURES

Unique content helps you get promising drug candidates to market fasterPharmaPendium offers preclinical and clinical safety, pharmacokinetic and drugenzyme

interaction data that cannot be found anywhere else. It also provides access to awhole range of medical and drug development journals along with references from Meyler’sSide Effects of Drugs and Mosby’s Drug Consult, enabling better drug candidateassessments.

1.73M

pages of FDA approvaldocuments

4000

drugs indexed and fullysearchable

100,000

pages of EMA approval documents

1.33M

pharmacokineticdata lines

5.25M

AERS reports

181,000

metabolizing enzyme & transporter data lines

490,000

pages from FDA Advisory Committee Meetings

1.26M

safetydata lines

Flexible search query options

PharmaPendium allows text searching with synonym recognition; structuresearching with structure similarity andsubstructure options; and browsing bycategories such as drug name, class ortarget, or adverse effect and toxicity.

Figure 1.

Optimized search query form with filters.

Increased access to regulatory documents

FDA, EMA and AERS documentscontain vast amounts of crucialpharmacokinetics data that neverreach academic publications. Theoptional Pharmacokinetics Module gives greater access to study results,including detailed preclinical and clinicalexposure data extracted from the entirehistory of FDA approval packages and EMA documents. This historical contextsupports drug repurposing decisions.Also, by providing deeper insight intodifferences between FDA and EMA approvals, PharmaPendium helps

improve regulatory submissions.

Figure 2.

Pharmacokinetics data search results for gabapentin (Neurontin).

Drugenzyme and drugdruginteractions revealed

With more data on interactions betweendrugs and enzymes than any other database, the optional MetabolizingEnzymes Transporters Module enables accurate make key risk assessments on bioavailability, toxicity and more. Predicting drugdrug interactions and adverse effectsearly saves research time and resourcesand drives research forward.

Figure 3.

Results of a metabolizing enzymes andtransporters search with carbamazepine

as the key word.

KEY BENEFITS

• Better risk assessment of a drug candidate’s toxicity

• Detailed assessments of a drug candidate’s PK parameters and properties

• Better assessment of previouspreclinical experimental design including species selection

• Rapid evaluation of potentialdrugdrug interaction risks

• Increased chances of successfulsubmissions to regulatory authorities

Discover more at elsevier.com/PharmaPendium