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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

Sandeep Nema, Sandeep Nema, John D. Ludwig, 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 3: Regulations, Validation and the Future

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. 3 Volume Set

Sandeep Nema, John D. Ludwig
August 26, 2010

Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable...

Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality

Michael J. Akers
August 20, 2010

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions,...

Advanced Aseptic Processing Technology

James Agalloco, James Akers
July 23, 2010

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing...

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Third Edition

Louis Rey
June 15, 2010

Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this...

Generic Drug Product Development: Specialty Dosage Forms

Leon Shargel, Isadore Kanfer
March 25, 2010

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate...

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