Biologics are a rapidly emerging class of therapeutics that have succeeded clinically and
commercially due to their specificity and efficacy against various diseases including cancer …

The success of drug therapy is highly dependent on route of administration, and oral route of
administration is the most successful, popular, and patient friendly. However, the …

Drug-device combination products should be safe and effective for intended uses by
intended users under intended use environment during human factor (HF) studies. All …

Diseases of the joints affect over 10% of the world's population, resulting in significant
morbidity. There is an unmet need in strategies for specific delivery of therapeutics to the …

There is a concern that low atmospheric pressure typically encountered during shipment
could result in plunger-stopper displacement in prefilled syringes impacting sterility and …

The present study was designed to develop an efficient, safe, and patient-friendly dosage
form, for oral delivery of alfa-choriogonadotropin, used in the treatment of female …

This chapter provides an insightful overview of two transformative technologies in the realm
of additive manufacturing: semisolid extrusion printing (SEP) and 3D bioprinting. Semisolid …

In the present chapter, some background for the development of soft mist inhaler delivery
will be provided followed by an overview of patient, technical (device, formulation) and …

Biologic agents are novel immunomodulatory medications targeted to control disease
processes through modulation of inflammatory and immunologic pathways. They have …

This chapter discusses that biologics represent a challenge in formulation development due
to the issues. The inherent physicochemical and biological instability needs to be overcome …