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{ "item_title" : "Generic Drug Product Development", "item_author" : [" Leon Shargel", "Isadore Kanfer "], "item_description" : "This volume 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 the therapeutic equivalence of generic specialty drug products to brand name alternatives. The book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.", "item_img_path" : "https://covers1.booksamillion.com/covers/bam/0/84/937/786/0849377862_b.jpg", "price_data" : { "retail_price" : "255.00", "online_price" : "255.00", "our_price" : "255.00", "club_price" : "255.00", "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|Leon Shargel

Generic Drug Product Development : Specialty Dosage Forms

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Overview

This volume 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 the therapeutic equivalence of generic specialty drug products to brand name alternatives. The book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.

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Details

  • ISBN-13: 9780849377860
  • ISBN-10: 0849377862
  • Publisher: CRC Press
  • Publish Date: March 2010
  • Dimensions: 9.1 x 6.1 x 0.9 inches
  • Shipping Weight: 1.15 pounds
  • Page Count: 288

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