CGMP Radiosynthesis for Early Phase Clinical Trials
Radiolabeled
drugs are used in Human ADME and bio-availability studies. While
the regulatory requirements for traditional “cold” clinical trial
materials are well understood, the regulatory requirements for
radiolabeled are much less understood by industry. The synthesis of
radiolabeled compounds sometimes requires development of new
synthetic pathways which can be significantly different from the
traditional synthetic pathway. The radiolabeled drug can have
significantly different stability and impurity profiles from the
non-labeled drug and thus require special considerations. These special
considerations may pose challenges in terms of ensuring CGMP compliance
and safety for the patient during the clinical trial.
To download the whitepaper, click here.
To download the whitepaper, click here.
How to Evaluate Manufacturer-Provided Extractable Information
Most
pharmaceutical container/closure systems in use today are purchased
from component manufacturers, who often provide material
characterization information on their products. A common and often
expensive misstep is to assume manufacturer-provided information will
suffice as Extractables and Leachables (E&L) data. This paper will
help you understand what information regulators require in your filing,
provide questions to ask suppliers, and explain how to evaluate
manufacturer-provided information relative to your unique product.
To download the whitepaper, click here.
To download the whitepaper, click here.
