PHYSICS 213

Part I Formulation Approaches for Sterile Products 1 Basic Principles of Sterile Product Formulation Development .......... 3 Martin A. Joyce and Leonore C. Witchey-Lakshmanan 2 Molecule and Manu facturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins ........... 33 Ranjini Ramachander and Nitin Rathore 3 Polymer- and Lipid-Based Systems for Parenteral Drug Delivery..... 47 David Chen and Sara Yazdi 4 Formulation Approaches and Strategies for PEGylated Biothera...

Contents 1 Introduction .................................................. 1 Yvonne Bouwman-Boer, V’Iain Fenton-May, and Paul Le Brun 2 Prescription Assessment ......................................... 7 Andrew Lowey and Stefanie Melhorn 3 Availability of Medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Helena Jenzer and V’Iain Fenton-May 4 Oral Solids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...