Pharmaceutical Science

Manufacturing & Engineering

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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

7th Edition

Featured

Graham P. Bunn
February 18, 2019

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. C...

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products

3rd Edition

Sarfaraz K. Niazi
November 19, 2019

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a...

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products

3rd Edition

Sarfaraz K. Niazi
November 14, 2019

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a...

Freeze Drying of Pharmaceutical Products

1st Edition

Davide Fissore, Roberto Pisano, Antonello Barresi
November 12, 2019

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from...

Parenteral Medications, Fourth Edition

4th Edition

Sandeep Nema, John D. Ludwig
August 14, 2019

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been...

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

3rd Edition

Maik W. Jornitz
July 12, 2019

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification...

The Pharmaceutical Regulatory Process

2nd Edition

Ira R. Berry, Robert P. Martin
June 07, 2019

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by...

Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition

2nd Edition

Sarfaraz K. Niazi
April 15, 2019

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 product is determined during the formulation studies phase. Though the two disciplines overlap in...

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

7th Edition

Graham P. Bunn
February 18, 2019

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting....

Pharmaceutical Extrusion Technology

2nd Edition

Isaac Ghebre-Sellassie, Charles E. Martin, Feng Zhang, James DiNunzio
March 16, 2018

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix...

Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products

2nd Edition

Sarfaraz K. Niazi
February 26, 2018

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, they do have their own set of considerations in the formulation and manufacturing stages. Highlights from Liquid...

Biosimilar Drug Product Development

1st Edition

Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
March 07, 2017

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...

Clean Room Technology in ART Clinics: A Practical Guide

1st Edition

Sandro C. Esteves, Alex C. Varghese, Kathryn C. Worrilow
November 03, 2016

Regulatory agencies worldwide have issued directives or such requirements for air quality standards in embryology laboratories. This practical guide reviews the application of clean room technology or controlled environments specifically suited for Assisted Reproductive Technology (ART) Units. Its...

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