Cargando…

Therapeutic protein drug products : practical approaches to formulation in the laboratory, manufacturing, and the clinic /

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and inc...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Meyer, Brian K.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Oxford : Woodhead Pub., 2012.
Colección:Woodhead Publishing series in biomedicine ; no. 8.
Temas:
Acceso en línea:Texto completo

MARC

LEADER 00000cam a2200000Ia 4500
001 SCIDIR_ocn847549881
003 OCoLC
005 20231117044903.0
006 m o d
007 cr cn|||||||||
008 130114s2012 enka ob 001 0 eng d
010 |a  2012551083 
040 |a E7B  |b eng  |e pn  |c E7B  |d OCLCO  |d OHS  |d IDEBK  |d N$T  |d OPELS  |d MYG  |d OCLCF  |d OTZ  |d OCLCQ  |d OCLCO  |d UIU  |d OCLCQ  |d OCLCO  |d OCLCQ  |d OCLCA  |d UAB  |d U3W  |d OCLCO  |d D6H  |d OCLCQ  |d OCLCO  |d OCLCA  |d AUD  |d DCT  |d ESU  |d S2H  |d OCLCO  |d LUN  |d LVT  |d OCLCO  |d OCLCQ  |d CASUM  |d OCL  |d OCLCO 
015 |a GBB0D7048.  |2 bnb 
019 |a 875291009  |a 972074723  |a 1039528078  |a 1043393564  |a 1055240407  |a 1086500926  |a 1171124213  |a 1172088661  |a 1229225245 
020 |a 9781908818102  |q (electronic bk.) 
020 |a 1908818107  |q (electronic bk.) 
020 |z 9781907568183 
020 |z 1907568182 
035 |a (OCoLC)847549881  |z (OCoLC)875291009  |z (OCoLC)972074723  |z (OCoLC)1039528078  |z (OCoLC)1043393564  |z (OCoLC)1055240407  |z (OCoLC)1086500926  |z (OCoLC)1171124213  |z (OCoLC)1172088661  |z (OCoLC)1229225245 
050 4 |a RS431.P75  |b T44 2012eb 
060 4 |a QV 778 
072 7 |a MED  |x 071000  |2 bisacsh 
072 7 |a TC  |2 bicssc 
072 7 |a TEC  |2 eflch 
082 0 4 |a 615.19  |2 22 
245 0 0 |a Therapeutic protein drug products :  |b practical approaches to formulation in the laboratory, manufacturing, and the clinic /  |c edited by Brian K. Meyer. 
260 |a Oxford :  |b Woodhead Pub.,  |c 2012. 
300 |a 1 online resource (xxii, 181 pages) :  |b illustrations. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Woodhead Publishing series in biomedicine,  |x 2050-0289 ;  |v no. 8 
504 |a Includes bibliographical references and index. 
520 |a Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulationsA comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinicDiscusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles. 
505 0 |a Commercial therapeutic protein drug products -- A formulation method to improve the physical stability of macromolecular-based drug products -- Properties of protein formulations -- Material and process compatibility testing -- Compounding and filling: Drug substance to drug product -- Administration in the clinic -- Regulatory guidelines for the development of a biotechnology drug product. 
650 0 |a Protein drugs. 
650 0 |a Protein drugs  |x Dosage forms. 
650 0 |a Drugs  |x Design. 
650 0 |a Proteins. 
650 0 |a Drugs  |x Dosage forms. 
650 2 |a Drug Design  |0 (DNLM)D015195 
650 2 |a Proteins  |0 (DNLM)D011506 
650 2 |a Biopharmaceutics  |x methods  |0 (DNLM)D001702Q000379 
650 2 |a Dosage Forms  |0 (DNLM)D004304 
650 6 |a M�edicaments prot�eiques.  |0 (CaQQLa)201-0249096 
650 6 |a M�edicaments prot�eiques  |x Formes pharmaceutiques.  |0 (CaQQLa)201-0263778 
650 6 |a M�edicaments  |x Conception.  |0 (CaQQLa)201-0203461 
650 6 |a Prot�eines.  |0 (CaQQLa)201-0008150 
650 6 |a M�edicaments  |x Formes pharmaceutiques.  |0 (CaQQLa)201-0025596 
650 7 |a protein.  |2 aat  |0 (CStmoGRI)aat300206575 
650 7 |a MEDICAL  |x Pharmacology.  |2 bisacsh 
650 7 |a Proteins  |2 fast  |0 (OCoLC)fst01079711 
650 7 |a Drugs  |x Dosage forms  |2 fast  |0 (OCoLC)fst00898801 
650 7 |a Drugs  |x Design  |2 fast  |0 (OCoLC)fst00898790 
650 7 |a Protein drugs  |2 fast  |0 (OCoLC)fst01079679 
650 7 |a Protein drugs  |x Dosage forms  |2 fast  |0 (OCoLC)fst01079681 
655 4 |a Internet Resources. 
700 1 |a Meyer, Brian K. 
830 0 |a Woodhead Publishing series in biomedicine ;  |v no. 8. 
856 4 0 |u https://sciencedirect.uam.elogim.com/science/book/9781907568183  |z Texto completo 
856 4 0 |u https://sciencedirect.uam.elogim.com/science/book/9781907568183  |z Texto completo