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

✍ Scribed by Leon Shargel, Isadore Kanfer

Publisher: CRC Press
Year: 2013
Tongue: English
Leaves: 384
Series: Drugs and the Pharmaceutical Sciences
Edition: 2
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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 concerns. This second edition contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

📜 SIMILAR VOLUMES

Generic Drug Product Development: Solid

📁 Generic Drug Product Development: Solid Oral Dosage Forms

✍ Leon Shargel 📂 Library 📅 2004 🏛 CRC Press 🌐 English

Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of ge

Development of Generic Drug Products: So

📁 Development of Generic Drug Products: Solid Oral Dosage Forms

✍ Shargel L. (Ed), Kanfer I. 📂 Library 📅 2004 🌐 English

Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted

Generic Drug Development: Solid Oral Dos

📁 Generic Drug Development: Solid Oral Dosage Forms (Drugs and the Pharmaceutical Sciences)

✍ Leon Shargel 📂 Library 📅 2004 🏛 Informa Healthcare 🌐 English

DEVELOPING SOLID ORAL DOSAGE FORMS Pharm

📁 DEVELOPING SOLID ORAL DOSAGE FORMS Pharmaceutical Theory & Practice

📂 Library 🌐 English

Developing Solid Oral Dosage Forms. Phar

📁 Developing Solid Oral Dosage Forms. Pharmaceutical Theory And Practice

✍ Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu and William R. Porter (Ed 📂 Library 📅 2008 🏛 Academic Press 🌐 English

Developing Solid Oral Dosage Forms: Phar

📁 Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice

✍ Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu, William Porter 📂 Library 📅 2009 🏛 Academic Press 🌐 English

This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sc