Analytical Development
Name two common analytical techniques used in drug testing.
HPLC, Mass Spectrometry, ELISA, etc.
When is Formulations most influential in development?
During preclinical and early clinical trials.
How does Scientific Writing differ from Medical Writing?
Scientific is technical and data-heavy; Medical is more accessible and patient/clinician-focused.
What does Validation ensure in manufacturing?
That processes, equipment, and systems consistently meet quality standards.
Name one key question that analytical methods aim to answer about a drug.
What's in the drug? How much? Is it stable? Are there impurities?
What is the difference between formulations in pharmaceuticals vs. biologics?
Biologics require aseptic parenteral methods (e.g., injection), while pharmaceuticals can be oral, topical, etc.
Name two types of documents Scientific Writers produce.
Technical reports and journal articles.
What is the purpose of technology transfer in MS&T?
To move lab-scale processes into commercial manufacturing environments.
What is method transfer?
The handoff of validated analytical methods to the Quality Control (QC) team for routine testing.
What are excipients?
Inactive substances that aid formulation; examples: binders and preservatives.
Why is version control important?
To ensure documents reflect the most current and accurate data for compliance.
Name the three stages of equipment qualification.
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).