Sökt på: Böcker av Sarfaraz K. Niazi
totalt 41 träffar
Biosimilarity
Summary:The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory …
Handbook of Pharmaceutical Manufacturing Formulations
Providing methodologies that can serve as a reference point for new formulations, the second volume covers uncompressed solids, which include formulations of powders, capsules, …
Handbook of Pharmaceutical Manufacturing Formulations
While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, …
Handbook of Bioequivalence Testing
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 …
Filing Patents Online
The average cost of an uncomplicated patent application filing is about $10,000. This high cost can leave thousands of inventors out in the cold. Filing Patents Online: A …
Future of Pharmaceuticals
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made …
Fundamentals of Modern Bioprocessing
Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job …
Handbook of Preformulation
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 …
Handbook of Biogeneric Therapeutic Proteins
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that …
Biosimilars and Interchangeable Biologics
What’s the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological …
Handbook of Biogeneric Therapeutic Proteins
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that …
Biosimilars Development Strategies
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of …