Pharmaceutical Science

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Analytical Similarity Assessment in Biosimilar Product Development

1st Edition

Shein-Chung Chow
August 01, 2018

This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of...

Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

1st Edition

Syed Imtiaz Haider
July 31, 2018

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them...

Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

1st Edition

Syed Imtiaz Haider, Syed Erfan Asif
July 31, 2018

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses...

Biosimilarity: The FDA Perspective

1st Edition

Sarfaraz K. Niazi
July 25, 2018

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 limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of...

In-Vitro and In-Vivo Tools in Drug Delivery Research for Optimum Clinical Outcomes

1st Edition

Ambikanandan Misra, Aliasgar Shahiwala
June 27, 2018

This book covers the essentials of drug delivery research and provides a unique forum for scientific experimental methods that are exclusively focused by the in-vitro, ex-vivo, and in-vivo methodologies of drug delivery research and felicitates translational research. The book includes recent and...

Physico-Chemical Properties of Nanomaterials

1st Edition

Richard C. Pleus, Vladimir Murashov
June 27, 2018

Throughout human history, we have long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies. Nanotechnology is a recent example of an emerging technology that promises to drastically improve existing products as well as allow for creative development...

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R

1st Edition

Jianrong Wu
June 18, 2018

Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with...

Biology and Ecology of Pharmaceutical Marine Plants

1st Edition

Ramasamy Santhanam, Santhanam Ramesh, Hafiz Ansar Rasul Suleria
June 12, 2018

Key features: A standard reference for researchers, teachers and students of Marine Biology, Fisheries Science, Botany/Plant Science, Biotechnology, Natural Products, and Pharmacy, their libraries A valuable guide for pharmaceutical companies involved in the development of new drugs from...

The Renal Drug Handbook: The Ultimate Prescribing Guide for Renal Practitioners, 5th Edition

5th Edition

Caroline Ashley, Aileen Dunleavy
June 12, 2018

This invaluable guide, endorsed by the UKMi and reflecting the extensive experience of the UK Renal Pharmacy Group, features drug monographs guiding physicians in how to prescribe, prepare, and administer drugs to patients with different levels of kidney function and when undergoing renal...

Statistics for Biotechnology Process Development

1st Edition

Todd Coffey, Harry Yang
June 05, 2018

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of...

Lipase: An Industrial Enzyme Through Metagenomics

1st Edition

B.K. Konwar, Kalpana Sagar
May 24, 2018

Microbial lipases are industrially important and have gained attention due to their stability, selectivity, and broad substrate specificity. Lipases are used as medicine, and they also aid in indigestion, heartburn, allergy to gluten in wheat products (celiac disease), Crohn’s disease, and cystic...

Bioprocess Engineering for a Green Environment

1st Edition

V. Sivasubramanian
May 08, 2018

Bioprocess Engineering for a Green Environment examines numerous bioprocesses that are crucial to our day-to-day life, specifically the major issues surrounding the production of energy relating to biofuels and waste management. The nuance of this discussion is reflected by the text’s chapter...

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