The evolution of an RCE’s suspension formulation, from pre-GLP studies to the pharmacy shelf

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Register for free : https://www.pharmtech.com/pt/Pre-GLP

Event overview:

This presentation focuses on the development of suspension formulations of an NCE for oral administration.

Starting with the simple formulations used in safety studies, through the multi-dose product used for clinical programs and up to the advanced long shelf life product that is commercialized. Aspects of formulation and analysis will be addressed.

Suspensions for other routes of administration, eg, IM or SC injections and eye drops, are beyond the scope of this presentation.

Key learning objectives:

  • Participants will understand that:
    • The complexity of the formulation increases during the development of a compound
    • Analytical testing requirements also increase during development
    • Several aspects of API characterization should be considered

Who should attend:

  • Scientific formulation
  • Scientific Director
  • VP Research and Development

Speakers

David Barnes PhD
Vice President for Scientific Affairs
Pace® Life Sciences

Dave graduated in Pharmacy from the School of Pharmacy, U. of London (“The Square”). After completing a year of internship in pharmacy, he returned to the School of Pharmacy to undertake a doctorate. in pharmaceutical sciences.

Dave then joined the R&D division of Pfizer in Sandwich, England, and for the next 13 years worked on the development of pharmaceutical products based on locally discovered molecules, from early pre-formulation to market launch. scale and transfer to production sites in Europe and the United States.

In 2001, with the acquisition of Parke-Davis, Dave moved to Ann Arbor to complete construction and commissioning of the new Pharmaceutical Sciences Building (550/TDF). Following the successful start-up of the facility, he joined the Clinical Trial Materials Department, managing operations at the Ann Arbor, Kalamazoo and Groton, CT sites.

In 2008, with the closure of the Ann Arbor plant, Dave partnered with Gerry Cox to create Velesco Pharmaceutical Services, which provides formulation and analytical development services to small and medium-sized pharmaceutical companies, as well as supplying of non-sterile products on a small scale. Supplies cGMP for early stage clinical studies.

In 2021, Velesco became a member of the Pace® Life Sciences laboratory network. Dave is now Vice President of Scientific Affairs at Pace® Life Sciences in Wixom, MI.

Register for free : https://www.pharmtech.com/pt/Pre-GLP

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