Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Doctors and Scientists

Formulation Development

Case Study: Using Formulation Development and PK Modeling to Develop New Intellectual Property

Formulation development is often overlooked in the mad dash to the clinic. If your drug is stable, soluble, and well-absorbed, then the choice of formulation may have little impact, but most new chemical entities are not that well behaved. Having a good formulation could be critical to success in early stage clinical studies.

PharmaDirections’ formulation experts apply decades of experience to each project. Rather than limiting ourselves to the capabilities found within a single CRO, we use a "Best-of-Breed" approach to select the scientists and organizations most appropriate for the type of dosage form desired. While all CROs claim to be good at everything, we know who is best at what, and we know how to combine the talents of our scientists and theirs in designing experiments and in generating and testing product prototypes.

Formulation development is both an art and a science, and in cases where formulation is critical to product success, there is no substitute for the knowledge, thinking ability, and experience that PharmaDirections’ scientists can provide.

Dosage Forms

Case Study: Reformulation to Achieve Acceptable Stability Profile

Case Study: Development of a Once Daily Oral Product

White Paper - Amorphous Dispersions in Formulation Development White Paper - Amorphous Dispersions in Formulation Development (39 KB)

White Paper - Injecting Amorphous Dispersions White Paper - Injecting Amorphous Dispersions (61 KB)