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[null,"1.","Record Nr.",null,"UNISA996392281403316"]
[null,null,"Autore",null,"Aesop"]
[null,null,"Titolo",null,"The fables of Esope in English [[electronic resource] ] : with al his life and fortune, how he was subtil, wise, and borne in Greece ... Whereunto is added the fables of Auicen [sic]: and also the fables of Alphonce, with the fables of Poge the Florentine, very pleasant to reade"]
[null,null,"Pubbl/distr/stampa",null,"London, : Printed [by J. Orwin] for Thomas Adams dwelling in Paules Church-yard at the signe of the white lion, 1596"]
[null,null,"Descrizione fisica",null,"[2], 247, [9] p"]
[null,null,"Soggetti",null,"Fables, Classical"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Translated by William Caxton."]
[{"$nulls":4},"Avicen = Avianus."]
[{"$nulls":4},"Includes the life of Aesop by Maximus Planudes."]
[{"$nulls":4},"Printer's name from STC."]
[{"$nulls":4},"With nine final contents pages."]
[{"$nulls":4},"Reproduction of the original in the Henry E. Huntington Library and Art Gallery."]
[null,null,null,"Sommario/riassunto","eebo-0113"]
[null,"2.","Record Nr.",null,"UNISALENTO991003865319707536"]
[null,null,"Autore",null,"Bernstein, Ossip Samoilovich"]
[null,null,"Titolo",null,"64 parties d'échecs / O.S. Bernstein ; présentées ou annotées par J. Cena"]
[null,null,"Pubbl/distr/stampa",null,"[S.l. : s.n., 197.]"]
[null,null,"Descrizione fisica",null,"1 v. ; 21 cm"]
[null,null,"Disciplina",null,"794.12"]
[null,null,"Soggetti",null,"Scacchi - Tornei"]
[null,null,"Lingua di pubblicazione",null,"Francese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,"3.","Record Nr.",null,"UNINA9910337940703321"]
[null,null,"Autore",null,"Geigert John"]
[null,null,"Titolo",null,"The Challenge of CMC Regulatory Compliance for Biopharmaceuticals  / / by John Geigert"]
[null,null,"Pubbl/distr/stampa",null,"Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019"]
[null,null,"ISBN",null,"3-030-13754-6"]
[null,null,"Edizione",null,"[3rd ed. 2019.]"]
[null,null,"Descrizione fisica",null,"1 online resource (338 pages)"]
[null,null,"Disciplina",null,"615.7"]
[{"$nulls":4},"615.19"]
[null,null,"Soggetti",null,"Pharmacology"]
[{"$nulls":4},"Pharmacy"]
[{"$nulls":4},"Pharmacology/Toxicology"]
[{"$nulls":4},"Drug Safety and Pharmacovigilance"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,"Nota di contenuto",null,"Complexity of Biologics CMC Regulation -- Biopharmaceutics are Not Chemical Drugs -- An Effective CMC Strategy is Possible -- Challenge of Adventitious Agent Control -- Biopharmaceutical Source Materials -- Manufacturing of Biopharmaceutical APIs -- Manufacturing of the Drug Product -- Complex Process-Related Impurity Profiles -- Product Characterization is a Journey -- Priceless Potency (Therapeutic Activity) -- Quality Attributes of a Biopharmaceutical -- Designing the Stability Program -- The Art of Setting Specifications -- Demonstrating Product Comparability After Process Changes -- Invaluable CMC-Focused Meetings with Regulatory Authorities."]
[null,null,null,"Sommario/riassunto","This book since first published in 2004 has been a major resource providing insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of "]
[{"$nulls":4},"expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals."]