Regulatory Aspects of Gene Therapy and Cell Therapy Products

A Global Perspective

  • Maria Cristina Galli
  • Mercedes Serabian

Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 871)

Also part of the American Society of Gene & Cell Therapy book sub series (ASGCT, volume 871)

Table of contents

  1. Front Matter
    Pages i-xii
  2. Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, Steve Winitsky
    Pages 1-29
  3. Marina O’Reilly, Robert Jambou, Eugene Rosenthal, Maureen Montgomery, Morad Hassani, Linda Gargiulo et al.
    Pages 31-47
  4. Anthony Ridgway, Francisca Agbanyo, Jian Wang, Michael Rosu-Myles
    Pages 49-71
  5. Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, Silke Schuele
    Pages 87-101
  6. Paula Salmikangas, Martina Schuessler-Lenz, Sol Ruiz, Patrick Celis, Ilona Reischl, Margarida Menezes-Ferreira et al.
    Pages 103-130
  7. Daisuke Maeda, Teruhide Yamaguchi, Takami Ishizuka, Masakazu Hirata, Kazuhiro Takekita, Daisaku Sato
    Pages 147-162
  8. Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, Won Shin
    Pages 163-179
  9. Yi-Chu Lin, Po-Yu Wang, Shih-Chih Tsai, Chien-Liang Lin, Hsuen-Yung Tai, Chi-Fang Lo et al.
    Pages 181-194
  10. Choon Wee Goh, Srinivasan N. Kellathur, Lee Lee Ong, Xiaofeng Wu
    Pages 195-212
  11. Back Matter
    Pages 221-230

About this book

Introduction

Medical literature for health care practitioners on the evaluation and treatment of breastfeeding issues has been disjointed, conflicting, and difficult to find. The field of breastfeeding medicine itself is nonexistent—there are no "breastfeeding doctors" who are specifically trained to understand this complex and interactive process. While much of the literature about breastfeeding describes how it "should" work, there is currently nothing available to explain why it often fails and how to treat it.

Clinician’s Guide to Breastfeeding: Evidence-based Evaluation and Management is written for health care practitioners who work with breastfeeding mothers; physicians, nurses, nurse practitioners, and lactation consultants. It provides clear information and clinically tested strategies to help professionals guide new mothers to breastfeed successfully. The first of its kind to consider the entirety of the breastfeeding experience, Clinician’s Guide to Breastfeeding is written by Dr. Linda D. Dahl, a leading expert on the subject. It is a comprehensive review of breastfeeding, covering objective analyses of ideal or “normal” nursing, as well as the evaluation and treatment of abnormal nursing, including case studies to illustrate the treatment decision-making process.

Keywords

Cell therapy Cell therapy products Gene therapy Regulatory oversight Regulatory policies

Editors and affiliations

  • Maria Cristina Galli
    • 1
  • Mercedes Serabian
    • 2
  1. 1.Cell Biology and NeurosciencesIstituto Superiore di SanitàRomeItaly
  2. 2.Center for Biologics Evaluation and Research/Office of Cellular, Tissue, and Gene TherapiesPharmacology/Toxicology Branch, US Food and Drug AdministrationSilver SpringUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-18618-4
  • Copyright Information American Society of Gene and Cell Therapy 2015
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-319-18617-7
  • Online ISBN 978-3-319-18618-4
  • Series Print ISSN 0065-2598
  • Series Online ISSN 2214-8019
  • About this book
Industry Sectors
Biotechnology
Pharma