As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the
Even the most established companies have made mistakes when developing biosimilar products. For example, not appreciating the future threats to intellectual property caused a biosimilar product develo
Handbook of Biogeneric Therapeutic Proteins is the first book to offer extensive coverage of all aspects of generic and biosimilar biological products, from the scientific basis through the marketing
Over-the-Counter products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separ
The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first vo
Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug
An authoritative and practical guide to the art and science of formulating drugs.With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug App
Even the most established companies have made mistakes when developing biosimilar products. For example, not appreciating the future threats to intellectual property caused a biosimilar product develo
Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the
Describes various steps in filing and prosecuting an online patent. This book teaches the methods of research, planning, and the art of writing winning claims that will result in commercially valuable
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not app
