{"product_id":"nonclinical-development-of-novel-biologics-biosimilars-vaccines-and-specialty-biologics-hardback-9780123948106","title":"Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics (Hardback) 9780123948106","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eNonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cp\u003eA wide-ranging reference detailing the process of preclinical safety assessment of all types of biologics, including vaccines, biosimilars, novel biopharmaceuticals and more\u003c\/p\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eLisa Plitnick (Edited by), Danuta Herzyk (Edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780123948106, Elsevier Science\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 29 August 2013\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e432 pages, 50 illustrations\u003cbr\u003e23.4 x 19 x 2.8 cm, 1.07 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\"…brings nonclinical testing of biological and follow-on biological drugs, vaccines plus cell and gene therapy drugs right up to date. It is written in a very readable, yet highly scientific manner and most of the relevant publications…on the topic are referenced…Overall, a ‘must read’ book for all in the nonclinical field of developing biological drugs.\" --\u003cb\u003ebtsNews, June 2014\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\"Researchers in pharmaceuticals, toxicology, and other biological sciences summarize the current status of developing medicines from biological material, pointing out where the process is different from developing small-molecule medicines and where it is the same. The topics include regulatory guidelines and their application in the non-clinical evaluation of biological medicines, early de-risking strategy for novel biotherapeutics…\" --\u003cb\u003eReference \u0026amp; Research Book News, December 2013\u003c\/b\u003e\u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003ci\u003eNonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics\u003c\/i\u003e is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface Acknowledgement Dedication\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection I: Biopharmaceuticals\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1. Novel Biopharmaceuticals  2. Global Regulatory Guidances 3. Early de-risking strategies for Novel Biopharmaceuticals vs. Small Molecule Drugs   4. PK\/PD assessments and Assays 5. Antibody-Drug Conjugates\u003c\/p\u003e \u003cp\u003e \u003cb\u003eSection II: Biosimilar Therapeutics\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6. Description of Biosimilar Therapeutics and  Compare\/contrast Biosimilar Therapeuticss and Novel Biopharmaceuticals  7. Global Regulatory Guidelines 8. Early characterization of Biosimilar Therapeutics vs. Novel Biopharmaceuticals\/Studies Required and Principles of Study Design\/PK\/PD assessments\/Assays\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection III: Vaccines\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9. Vaccines Description and Comparison\/Contrast of Vaccines and Novel Biopharmaceuticals 10. Global Regulatory Guidances 11. Early de-risking strategies for Vaccines vs. Novel Biopharmaceuticals  \u003c\/p\u003e \u003cp\u003e\u003cb\u003eSection IV: Specialty Biologics and Indications\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12. Cell Therapies 13. Gene Therapies 14. Blood Products 15. Oncology Drugs 16. Dual and Multi-Function Modalities 17. Stem Cell-Based Therapeutics\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Pharmaceutical technology [\u003ca title=\"See our other books on Pharmaceutical technology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmaceutical%20technology%20%5BTDCW%5D%22\"\u003eTDCW\u003c\/a\u003e], Scientific standards [\u003ca title=\"See our other books on Scientific standards\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Scientific%20standards%20%5BPDD%5D%22\"\u003ePDD\u003c\/a\u003e], Medical toxicology [\u003ca title=\"See our other books on Medical toxicology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Medical%20toxicology%20%5BMMGT%5D%22\"\u003eMMGT\u003c\/a\u003e], Pharmacology [\u003ca title=\"See our other books on Pharmacology\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Pharmacology%20%5BMMG%5D%22\"\u003eMMG\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Academic Press","offers":[{"title":"Default Title","offer_id":46648514445592,"sku":"9780123948106","price":110.99,"currency_code":"GBP","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/products\/9780123948106.jpg?v=1694092004","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/nonclinical-development-of-novel-biologics-biosimilars-vaccines-and-specialty-biologics-hardback-9780123948106","provider":"Freshly Printed Books","version":"1.0","type":"link"}