Translational Pharmaceutics® can be applied for rapid formulation and clinical testing
Today, most new drugs require some formulation optimization during development to transition from early development formulation to one suitable for administration. Formulation optimization is also a common part of a drug lifecycle management strategy.
Applying the Translational Pharmaceutics® platform to drug product optimization for either a new chemical entity (NCE) or during life-cycle management of an existing drug allows for the unique inclusion of a formulation design space in initial regulatory submissions and clinical protocols.
This design space approach lets us iteratively optimize the composition of critical-to-performance excipients and dosage strengths relative to clinical performance to achieve your target product profile (TPP).
Over 300 programs completed.
Trusted for over 17 years.
A unique application to optimize drug products.
RapidFACT® programs, an application of the Translational Pharmaceutics® platform, focus exclusively on drug product optimization. See how we enable a faster, integrated approach to drug development.
Maximizes flexibility
by allowing you to fine-tune drug product formulations.
Timeline acceleration
by reducing the chemistry, manufacturing, and controls (CMC) data package needed for your clinical assessments.
API Savings
that helps remove drug product scale-up from the critical path.
How to use Translational Pharmaceutics® to advance your next early development program
Beyond optimizing drug products, see how else Translational Pharmaceutics® can be applied to drug programs in these applications.
- Translational Pharmaceutics® for accelerating first-in-human, Phase I testing
Reach a pivotal milestone with our phase-specific drug product to test the safety and tolerability of your drug.
- AI-enhanced formulation development within Translational Pharmaceutics®
Discover our new proprietary AI solution, combining Quotient Sciences intelligence with the power of AI, to achieve formulation decisions up to 50% faster.
- Translational Pharmaceutics® for drug product optimization in Phase Ib/IIa studies
Simplify reformulation after Phase I and beyond to manage product lifecycle, ensure continued innovation, and meet trial success.
- Translational Pharmaceutics® for more efficient, integrated human ADME studies
Whether for New Drug Applications (NDA) or in parallel with Phase II / proof-of-concept studies, we integrate services to ensure better ADME study outcomes.