My company has problems getting samples of the wide concentration range specified in the protocol. What I can do?
The protocol is designed to cover the concentration range expected for the population. Manufacturers have two options available when some ranges are difficult to cover. First, the manufacturer can arrange with a local clinical laboratory or lipid research clinic to obtain samples (as long as privacy regulations are followed). Second, the manufacturer can arrange with the CRMLN laboratory to provide samples (as long as the samples are fresh when analyzed by the manufacturer’s test method). When CRMLN laboratories provide samples, the manufacturer will incur an additional charge.
