Flexible Studies

Traditional Phase I studies are often constrained by pre-defined formulation and dosing options.  The challenge is to incorporate protocol flexibility to allow evaluation of formulation and delivery options, maximising bioavailability of a new drug as it moves into Phase II.

At Quotint Bioresearch we have pioneered the use of flexible clinical protocol designs to maximise the delivery of pivotal data for formulation design and delivery.  We take a science-driven approach to early drug development, applying innovative technologies and techniques.  This delivers the most valuable information on which to base further development decisions.

Our flexible approach allows the definition of doses, formulation types or other delivery options on the basis of data obtained earlier in the same study.

Flexible options include:

• We can incorporate decision points into single ascending dose (SAD) or multiple ascending dose (MAD) studies, enabling final decisions on precise dose levels to be made during the study using data from earlier study legs.
• We can incude a microdose intravenous "cassette" leg with accelerator mass spectrometry (AMS) analysis following SAD/MAD regimens.  This helps to interpret sub-optimal PK data.
• We provide options for testing additional gastrointestinal (GI) absorption sites using the Enterion capsule on the basis of data obtained earlier in the same study.
• We can test additional formulation prototypes on the basis of earlier data obtained in the same study.
• Fed or fasted study legs can be introduced, depending on earlier results.

Our innovative approaches have been approved by the FDA and the EMEA.  We continue to work closely with regulatory authorities as we incorporate new technologies and processes aimed at streamlining the early development process.