Frank A. Chrzanowski, Ph.D. is a
Pharmaceutical Consultant, Pharmaceutical Development Scientist, and Expert Witness having more than 30 years experience in the field. He has been an Expert Witness for US and Canadian Pharma Companies and Law Firms in
Pharmaceutical Formulation Patent Litigation, including Hatch-Waxman Innovator vs. Generic Products, In-Licensing Due Diligence, and Civil Suits involving Commissions and Technology.
Dr. Chrzanowski's overall experience has resulted in highly developed management and writing skills, and an extremely wide range of direct and indirect product development experiences in multi-national large, medium, small and virtual Pharma companies.
Dr. Chrzanowski's background includes 20 years at Johnson & Johnson Family of Companies as a Pharmaceutical Development Scientist/Manager. He is currently Pilot Plant Operations Manager for 4 years for a new, novel Drug Delivery and Medical Device Company, responsible for all services and establishing cGMP mindset. He is the author of 15 published Manuscripts, 12 Meeting Abstracts, 19 Invited Symposia, Seminars and Courses, and 5 Articles in Pharmaceutical Magazines.
Core Specialties Include:
- CMC Development Issues
- Preformulation
- Physical-Pharmacy
- Analytics
- cGMP Operations
- Project Planning and Management
View Consulting Profile.
Two numerical methods, Decision Analysis (DA) and Potential Problem Analysis (PPA) are presented as alternative selection methods to the logical method presented in Part I.
Abstract. The physical-chemical properties of interest for Controlled Release (CR) dosage form development presented are based on the author's experience. Part I addresses selection of the final form based on a logical progression of physical-chemical properties evaluation of candidate forms and elimination of forms with undesirable properties from further evaluation in order to simplify final form selection.
Abstract. Practical examples of preformulation support of the form selected for formulation development are provided using several drug substances (DSs). The examples include determination of the solubilities vs. pH particularly for the range pH 1 to 8 because of its relationship to gastrointestinal (GI) conditions and dissolution method development.
