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{ "item_title" : "Introduction to Biologic and Biosimilar Product Development and Analysis", "item_author" : [" Karen M. Nagel "], "item_description" : "1. Principles of Recombinant DNA Technologya. Introductionb. Production methodsc. Purification technologyd. Characterizatione. Analysis and regulationf. Summary points2. Therapeutic Proteinsa. Introduction: Protein/peptide structure and what that means for deliveryb. Delivery challengesc. Potential methods of deliveryd. Summary points3. Therapeutic Antibodiesa. Drug development and antibody engineeringb. Pharmacokinetics of monoclonal antibodiesc. Delivery methodsd. Clinical applicationse. Antibody-specific adverse effectsf. Therapeutic areasg. Summary points4. Analysis and Regulation of Biologics, Including Biosimilarsa. Introductionb. FD&C Act Section 505(b)(2) and the products that currently may be approved via this pathwayc. PHS Act / Biologics Price Competition and Innovation (BCPI) Act of 2009d. Summary Points", "item_img_path" : "https://covers1.booksamillion.com/covers/bam/3/03/007/492/3030074927_b.jpg", "price_data" : { "retail_price" : "129.99", "online_price" : "129.99", "our_price" : "129.99", "club_price" : "129.99", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }
Introduction to Biologic and Biosimilar Product Development and Analysis|Karen M. Nagel

Introduction to Biologic and Biosimilar Product Development and Analysis

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Overview

1. Principles of Recombinant DNA Technologya. Introductionb. Production methodsc. Purification technologyd. Characterizatione. Analysis and regulationf. Summary points2. Therapeutic Proteinsa. Introduction: Protein/peptide structure and what that means for deliveryb. Delivery challengesc. Potential methods of deliveryd. Summary points3. Therapeutic Antibodiesa. Drug development and antibody engineeringb. Pharmacokinetics of monoclonal antibodiesc. Delivery methodsd. Clinical applicationse. Antibody-specific adverse effectsf. Therapeutic areasg. Summary points4. Analysis and Regulation of Biologics, Including Biosimilarsa. Introductionb. FD&C Act Section 505(b)(2) and the products that currently may be approved via this pathwayc. PHS Act / Biologics Price Competition and Innovation (BCPI) Act of 2009d. Summary Points

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Details

  • ISBN-13: 9783030074920
  • ISBN-10: 3030074927
  • Publisher: Springer
  • Publish Date: January 2019
  • Dimensions: 9.21 x 6.14 x 0.26 inches
  • Shipping Weight: 0.41 pounds
  • Page Count: 109

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