Biosimilar Drug Product Development

Biosimilar Drug Product Development
Author: Laszlo Endrenyi
Publisher: CRC Press
Total Pages: 379
Release: 2017-02-24
Genre: Medical
ISBN: 1351646184

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 241
Release: 1990-02-01
Genre: Medical
ISBN: 0309042860

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

An Assessment of the National Institute of Standards and Technology Material Measurement Laboratory

An Assessment of the National Institute of Standards and Technology Material Measurement Laboratory
Author: National Research Council
Publisher: National Academies Press
Total Pages: 206
Release: 2015-01-15
Genre: Technology & Engineering
ISBN: 0309367433

The National Institute of Standards and Technology's (NIST's) Material Measurement Laboratory (MML) is our nation's reference laboratory for measurements in the chemical, biological, and materials sciences and engineering. Staff of the MML develop state-of-the-art measurement techniques and conduct fundamental research related to measuring the composition, structure, and properties of substances. Tools that include reference materials, data, and measurement services are developed to support industries that range from transportation to biotechnology and to address problems such as climate change, environmental sciences, renewable energy, health care, infrastructure, food safety and nutrition, and forensics. This report assesses the scientific and technical work performed by NIST's Material Measurement Laboratory. In particular, the report assesses the organization's technical programs, the portfolio of scientific expertise within the organization, the adequacy of the organization\'s facilities, equipment, and human resources, and the effectiveness by which the organization disseminates its program outputs.