Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these element...

Πλήρης περιγραφή

Λεπτομέρειες βιβλιογραφικής εγγραφής
Συγγραφή απο Οργανισμό/Αρχή:	SpringerLink (Online service)
Άλλοι συγγραφείς:	Jameel, Feroz (Επιμελητής έκδοσης), Hershenson, Susan (Επιμελητής έκδοσης), Khan, Mansoor A. (Επιμελητής έκδοσης), Martin-Moe, Sheryl (Επιμελητής έκδοσης)
Μορφή:	Ηλεκτρονική πηγή Ηλ. βιβλίο
Γλώσσα:	English
Έκδοση:	New York, NY : Springer New York : Imprint: Springer, 2015.
Σειρά:	AAPS Advances in the Pharmaceutical Sciences Series, 18
Θέματα:	Medicine. Pharmacology. Biomedicine. Pharmacology/Toxicology. Biomedicine general.
Διαθέσιμο Online:	Full Text via HEAL-Link

Παρόμοια τεκμήρια

Biopharmaceutics Applications in Drug Development
Έκδοση: (2008)

Biopharmaceutical Drug Design and Development
Έκδοση: (2008)

Immunogenicity of Biopharmaceuticals
Έκδοση: (2008)

Insights into Receptor Function and New Drug Development Targets
Έκδοση: (2006)

Drug and Biological Development From Molecule to Product and Beyond /
Έκδοση: (2007)

The Science and Business of Drug Discovery Demystifying the Jargon /
ανά: Zanders, Edward D.
Έκδοση: (2011)

Drug Product Development for the Back of the Eye
Έκδοση: (2011)

Drug-related problems in the elderly
ανά: Midlöv, Patrik, κ.ά.
Έκδοση: (2009)

Natural Compounds as Drugs Volume II /
Έκδοση: (2008)

Cardiac Safety of Noncardiac Drugs Practical Guidelines for Clinical Research and Drug Development /
Έκδοση: (2005)

Membrane Transporters as Drug Targets
Έκδοση: (2002)

Optimizing the “Drug-Like” Properties of Leads in Drug Discovery
Έκδοση: (2006)

Drugs of Abuse Body Fluid Testing /
Έκδοση: (2005)

Drug Addiction From Basic Research to Therapy /
Έκδοση: (2008)

Natural Compounds as Drugs Volume I
Έκδοση: (2008)

Drug Discovery and Evaluation Pharmacological Assays /
Έκδοση: (2008)

Drug Discovery and Evaluation Safety and Pharmacokinetic Assays /
Έκδοση: (2006)

Appropriate Dose Selection — How to Optimize Clinical Drug Development
Έκδοση: (2007)

Nanotechnology in Drug Delivery
Έκδοση: (2009)

Drug Metabolism and Pharmacokinetics Quick Guide
ανά: Khojasteh, Siamak Cyrus, κ.ά.
Έκδοση: (2011)

Drug Discovery and Evaluation: Methods in Clinical Pharmacology
Έκδοση: (2011)

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Έκδοση: (2013)

New Technologies for Toxicity Testing
Έκδοση: (2012)

Fundamentals and Applications of Controlled Release Drug Delivery
Έκδοση: (2012)

Pharmaco-Complexity Non-Linear Phenomena and Drug Product Development /
ανά: Hickey, Anthony J., κ.ά.
Έκδοση: (2011)

Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics
Έκδοση: (2007)

Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists
ανά: Kwon, Younggil
Έκδοση: (2002)

Dose Finding in Drug Development
Έκδοση: (2006)

Drugs for Relapse Prevention of Alcoholism
Έκδοση: (2005)

Anxiety and Anxiolytic Drugs
Έκδοση: (2005)

Formulation, Characterization, and Stability of Protein Drugs: Case Histories Case Histories /
Έκδοση: (2002)

Drug Treatment of Sleep Disorders
Έκδοση: (2015)

Pharmacology and Abuse of Cocaine, Amphetamines, Ecstasy and Related Designer Drugs A comprehensive review on their mode of action, treatment of abuse and intoxication /
ανά: Freye, Enno
Έκδοση: (2010)

Pharmacokinetic and Pharmacodynamic Drug Interactions Associated with Antiretroviral Drugs
Έκδοση: (2016)

Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices /
Έκδοση: (2009)

Oral Delivery of Macromolecular Drugs Barriers, Strategies and Future Trends /
Έκδοση: (2009)

Encyclopedia of Psychopharmacology
Έκδοση: (2015)

An Introduction to Toxicology
ανά: Burcham, Philip C.
Έκδοση: (2014)

Encyclopedia of Psychopharmacology
Έκδοση: (2010)

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
Έκδοση: (2009)

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