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Ensuring Quality Management of PK Samples from Collection to Archival and Selecting the Right Biorepository for Your Needs. Gina McMullen Sr. PK Research Associate ISIS Pharmaceuticals, Inc. Objectives: .
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Gina McMullenSr. PK Research AssociateISIS Pharmaceuticals, Inc.
Studies published in 2003 indicate the cost to bring a new drug to market is
around $800 million.[1,2] More recent studies estimate that cost to be as high as
$2,000 million, depending upon the therapy or the company developing it. 
IND Enabling Toxicology Studies
First in Human
StudiesPK Component of Drug Development Timelines
Up to1000 PK samples generated for analysis in a single IND enabling Toxicology study (nonhuman primate study)
Up to 1500 PK samples generated for analysis in a single Phase 1, FIH, SAD/MAD study design
(35-40 collected per patient)
Around 500-1000 PK samples generated from a single Phase 2A/2B study depending upon number of patients enrolled
(25-30collected per patient)
1000+ PK samples generated from a Phase 3 study, but only around 5-10 collected per patient (increased # patients enrolled)
Time to Market
The Importance of proper PK sample collection, processing, reporting, and eventual archival
container to ensure samples won’t
thaw in event of delays.
Two transfer tubes labeled identically:
1) Primary Aliquot for initial analysis
2) Duplicate Aliquot as a backup
EDTA collection tube
Ensure frozen immediately
at appropriate temperature
Proper identification at PK
Lab is essential to accurate data reporting
i.e. 1500g for
15 min @ 4oCOverview of PK Sample Collection to Data Reporting
Use validated methods for
PK analysis under GLP
compliance to ensure
quality final data.
Ship to PK Lab for Analysis
Analyze samples and report data
Split into 2 equal aliquots
Study Considerations in order to ensure sample viability for future use
Protocol Planning for Sample Collection
Eventual Sample Archival
Patient information and sampling information
Airway Bill Number and comments
Number of specimens collected/ name, signature and date
Send the white copy of the form with ambient specimens to Central Lab.
Send the yellow copy of the form with frozen specimens to Central Lab.
Retain the pink copy at clinical site.Documentation of Proper PK Sample Collection in a Clinical Trial
Complete and check all the information on the Laboratory Requisition Form
Ensure the Laboratory Requisition Form is complete and legible. If an error is made, strike-through the wrong information without obscuring the original entry, correct it, sign and date the change.
Once completed, this form must be faxed to the Central Lab the day of sample collection. This is for tracking purposes.
Please use the forms as follows:
Choosing the Right Biorepository for long term storage needs
Interaction (ensuring quality communication with your chosen Biorepository):
…which can ultimately add value to your drug development program!
We hope to see you in Philadelphia!
September 8 – 10, 2008