144,99 €
Produit Neuf
Ou 36,25 € /mois
- Livraison : 25,00 €
- Livré entre le 6 et le 12 octobre
Apres acceptation de la commande, le delai moyen d'expedition depuis le Japon est de 48 heures. Le delai moyen de livraison est de 3 a 4 semaines. En cas de circonstances exceptionnelles, les delais peuvent s'etendre jusqu'à 2 mois.
- Payez directement sur Rakuten (CB, PayPal, 4xCB...)
- Récupérez le produit directement chez le vendeur
- Rakuten vous rembourse en cas de problème
Gratuit et sans engagement
Félicitations !
Nous sommes heureux de vous compter parmi nos membres du Club Rakuten !
TROUVER UN MAGASIN
Retour
Avis sur Biosimilars Format Broché - Livre Sciences de la vie et de la terre
0 avis sur Biosimilars Format Broché - Livre Sciences de la vie et de la terre
Les avis publiés font l'objet d'un contrôle automatisé de Rakuten.
-
Collection Entremets & Petits Gâteaux
1 avis
Occasion dès 90,00 €
-
Catafalque
Neuf dès 86,94 €
-
I Want To Spend The Rest Of My Life Everywhere, With Everyone, One To One, Always, Forever, Now
Occasion dès 96,88 €
-
Behind Bars: The Definitive Guide To Music Notation
Neuf dès 101,68 €
-
By Marc Pairon Art Deco Ceramics Made In Belgium: Charles Catteau
6 avis
Occasion dès 110,00 €
-
Song Book - Intégrale --- Chant, Guitare Ou Piano
Occasion dès 100,00 €
-
Quantum Electrodynamics Of Strong Fields
Neuf dès 211,28 €
-
Geometric Quantization And Quantum Mechanics
Neuf dès 123,61 €
-
Harald Szeemann
Neuf dès 87,99 €
-
The Globalization Of World Politics
Neuf dès 87,03 €
-
Advanced Quantum Mechanics
Neuf dès 145,54 €
-
Te Linde's Operative Gynecology
Neuf dès 103,99 €
-
Cuento De Cuentos - Origen Y Aventura De Ciertas Palabras Y Frases Proverbiales
Occasion dès 120,00 €
-
Common Sense
Occasion dès 115,00 €
-
Götz Von Berlichingen
2 avis
Occasion dès 85,00 €
-
Custom Lettering Of The '60s & '70s
Occasion dès 162,00 €
-
The Twilight Saga Deluxe Hardcover Collection
Neuf dès 223,38 €
Occasion dès 85,00 €
-
Diego Rivera. The Complete Murals
Neuf dès 212,44 €
-
The Fourth World Omnibus Vol. 2
Neuf dès 134,88 €
-
Flashpoint: The 10th Anniversary Omnibus
Neuf dès 158,71 €
Produits similaires
Présentation Biosimilars Format Broché
- Livre Sciences de la vie et de la terre
Résumé : Written by a top biostatistics researcher, this is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. The book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
Biographie: Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke?National University of Singapore Graduate Medical School. He is the editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He has authored or co-authored over 230 papers and 22 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.
Sommaire: Introduction. Bioequivalence Experience for Small-Molecule Drug Products. Regulatory Requirement for Assessing Follow-On Biologics. Criteria for Similarity. Statistical Methods for Assessing Average Biosimilarity. General Approach for Assessing Biosimilarity. Non-Inferiority versus Equivalence/Similarity. Statistical Test for Biosimilarity in Variability. Sample Size for Comparing Variabilities. Impact of Variability on Biosimilarity Limits for Assessing Follow-On Biologics. Drug Interchangeability. Issues on Immunogenicity Studies. CMC Requirements for Biological Products. Test for Comparability in Manufacturing Process. Stability Analysis of Biosimilar Products. Assessing Biosimilarity Using Biomarker Data. Current Issues in Biosimilar Studies. References. Index.
Détails de conformité du produit
Personne responsable dans l'UE