Pharmaceutical Science

Manufacturing & Engineering

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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...

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms

4th Edition

Linda A. Felton
October 13, 2016

Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many...

Good Design Practices for GMP Pharmaceutical Facilities

2nd Edition

Terry Jacobs, Andrew A. Signore
June 27, 2016

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on...

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

1st Edition

Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee
March 03, 2016

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the...

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

2nd Edition

Leon Shargel, Isadore Kanfer
October 24, 2013

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory...

Encyclopedia of Pharmaceutical Science and Technology, Six Volume Set (Print)

4th Edition

James Swarbrick
July 01, 2013

Pharmaceutical science deals with the whole spectrum of drug development from start to finish. There are many different facets to the pharmaceutical industry, from initial research to the finished product, including the equipment used, trials performed, and regulations that must be followed....

Conferences

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