Pharmaceutical Science

Manufacturing & Engineering

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Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products

Sarfaraz K. Niazi
December 12, 2017

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

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

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, Fourth 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, Second 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

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

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, Fourth Edition, Six Volume Set (Print)

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....

Pharmaceutical Powder Compaction Technology, Second Edition

Metin Çelik
August 22, 2011

Compaction of powder constituents—both active ingredient and excipients—is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides...

Pharmaceutical Process Scale-Up, Third Edition

Michael Levin
February 02, 2011

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that...

Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition: Volume 2: Facility Design, Sterilization and Processing

Sandeep Nema, John D. Ludwig
August 26, 2010

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it...

Pharmaceutical Dosage Forms - Parenteral Medications, Third Edition: Volume 1: Formulation and Packaging


August 26, 2010

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it...

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