{
"item_title" : "Generic Drug Product Development",
"item_author" : [" Leon Shargel", "Isadore Kanfer "],
"item_description" : "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. In this volume, more than 30 noted specialists describe the development of generic drug products-from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. This second edition includes discussion on the relationship between the FDA and the United States Pharmacopeia and the application of Quality by Design (QbD) during formulation development. ",
"item_img_path" : "https://covers4.booksamillion.com/covers/bam/1/42/008/635/1420086359_b.jpg",
"price_data" : {
"retail_price" : "310.00", "online_price" : "310.00", "our_price" : "310.00", "club_price" : "310.00", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : ""
}
}
Generic Drug Product Development : Solid Oral Dosage Forms, Second Edition
by Leon Shargel and Isadore Kanfer
Other Available Formats
Overview
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. In this volume, more than 30 noted specialists describe the development of generic drug products-from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. This second edition includes discussion on the relationship between the FDA and the United States Pharmacopeia and the application of Quality by Design (QbD) during formulation development.
This item is Non-Returnable
Customers Also Bought
Details
- ISBN-13: 9781420086355
- ISBN-10: 1420086359
- Publisher: CRC Press
- Publish Date: October 2013
- Dimensions: 9.3 x 6.1 x 0.9 inches
- Shipping Weight: 1.5 pounds
- Page Count: 397
Related Categories
