Best practices for the development, scale-up, and post-approval change control of IR and MR dosage forms in the current quality-by-design paradigm.

In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies.

Mechanisms of arm-tip regeneration in the sea star, Leptasterias hexactis.

Wound healing and regeneration following amputation of arm-tips of the sea star, Leptasterias hexactis, are described using light microscopy, SEM, TEM, and [H] thymidine autoradiography. The process can be divided into a number of stages. Initially, the wound is closed by contractions of the stump-tip.