2013, ISBN: 9780123948106

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a timely and comprehensive look at the process of nonclinical safety assessment of different types of bi… More...

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a timely and comprehensive look at the process of nonclinical safety assessment of different types of biopharmaceuticals or biologics. Biologic drugs are a growing and crucial part of the overall pharmaceutical market, largely and generally because they are slightly cheaper to produce, provide higher profit margins and have a higher approval rate than conventional drugs. This reference includes the latest international guidance documents on nonclinical evaluation and a comprehensive review of vaccines, novel biopharmaceuticals, biosimilars and other biologics. By incorporating early de-risking strategies and principles of study design for each type of biopharmaceutical and comparing each to small molecule drugs, this multi-authored book is a valuable resource for all those involved in biologics development. Buch (fremdspr.) Lisa (EDT)/ Herzyk, Danuta (EDT) Plitnick gebundene Ausgabe, Academic Pr Inc, 19.07.2013, Academic Pr Inc, 2013<

ISBN: 9780123948106

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a timely and comprehensive look at the process of nonclinical safety assessment of different types of bi… More...

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a timely and comprehensive look at the process of nonclinical safety assessment of different types of biopharmaceuticals or biologics. Biologic drugs are a growing and crucial part of the overall pharmaceutical market, largely and generally because they are slightly cheaper to produce, provide higher profit margins and have a higher approval rate than conventional drugs. This reference includes the latest international guidance documents on nonclinical evaluation and a comprehensive review of vaccines, novel biopharmaceuticals, biosimilars and other biologics. By incorporating early de-risking strategies and principles of study design for each type of biopharmaceutical and comparing each to small molecule drugs, this multi-authored book is a valuable resource for all those involved in biologics development. Specialty Biologic Buch (fremdspr.) Bücher>Fremdsprachige Bücher>Englische Bücher, Academic Pr Inc<

ISBN: 9780123948106

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimila… More...

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics 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. Life Sciences Media > Printbook > Life Sciences Pharmaceutical Sciences Printbook, Academic Press<

ISBN: 9780123948106

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics: Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics: Büche… More...

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics: Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics: Bücher > Wissenschaft > Medizin, Elsevier LTD, Oxford<