LEADER 00000nam a2200469 i 4500 
001    978-3-319-18618-4 
003    DE-He213 
005    20160401104425.0 
006    m     o  d         
007    cr nn 008maaau 
008    150915s2015    gw      s         0 eng d 
020    9783319186184|q(electronic bk.) 
020    9783319186177|q(paper) 
024 7  10.1007/978-3-319-18618-4|2doi 
040    GP|cGP|erda|dAS 
041 0  eng 
050  4 RB155.8 
082 04 616.042|223 
245 00 Regulatory aspects of gene therapy and cell therapy 
       products :|ba global perspective /|cedited by Maria 
       Cristina Galli, Mercedes Serabian 
264  1 Cham :|bSpringer International Publishing :|bImprint: 
       Springer,|c2015 
300    1 online resource (xii, 230 pages) :|billustrations, 
       digital ;|c24 cm 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
347    text file|bPDF|2rda 
490 1  Advances in experimental medicine and biology,|x0065-2598 
       ;|vvolume 871 
505 0  1. Regulatory Oversight of Gene Therapy and Cell Therapy 
       Products in the US - FDA/CBER -- 2. US Oversight of Gene 
       Therapy Products - NIH RAC -- 3. Regulatory Oversight of 
       Gene Therapy and Cell Therapy Products in Canada - Health 
       Canada -- 4. Overview of the Regulatory Oversight 
       Implemented by the French Regulatory Authorities for the 
       Clinical Investigation of Gene Therapy and Cell Therapy 
       Products -- 5. Regulation of Clinical Trials with Advanced
       Therapy Medicinal Products (ATMP) in Germany -- 6. EU 
       Clinical Trials Regulatory Oversight of Advanced Therapy 
       Medicinal Products (ATMP): Perspectives from Various 
       Member States -- 7. Regulatory Oversight of Gene Therapy 
       and Cell Therapy Products in Switzerland - Swissmedic -- 
       8. Regulatory Oversight of Gene Therapy and Cell Therapy 
       Products in Japan - Japan Ministry of Health, Labour and 
       Welfare (MHLW) and Pharmaceutical and Medical Device 
       Agency (PMDA) -- 9. Regulatory Oversight of Gene Therapy 
       and Cell Therapy Products in Korea - Korean Ministry of 
       Food and Drug Safety (MFDS) -- 10. Regulatory Oversight of
       Gene Therapy and Cell Therapy Products in Taiwan - Taiwan 
       Food and Drug Administration (TFDA) -- 11. Regulatory 
       Oversight of Gene Therapy and Cell Therapy Products in 
       Singapore - Singapore Health Science Authorities (HSA) -- 
       12. Regulatory Oversight of Gene Therapy and Cell Therapy 
       Products in Brazil - National Health Surveillance Agency 
       (ANVISA) 
520    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 
650  0 Gene therapy|xGovernment policy 
650  0 Gene therapy|xLaw and legislation 
650 14 Biomedicine 
650 24 Gene Therapy 
700 1  Galli, Maria Cristina,|eeditor 
700 1  Serabian, Mercedes,|eeditor 
710 2  SpringerLink (Online service) 
773 0  |tSpringer eBooks 
830  0 Advances in experimental medicine and biology ;|vvolume 
       871 
856 40 |uhttp://dx.doi.org/10.1007/978-3-319-18618-4
       |zeBook(Springerlink)