Detailing formulation approaches by stage of discovery to early development, this book gives a "playbook" of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development.
- Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry
- Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research
- Features case studies to illustrate practical challenges and solutions in formulation selection
- Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
Elizabeth Kwong, PhD, retired from Merck & Co., Inc. in 2011, after 23 years of service. She then established her own company, Kwong Eureka Solutions, as a consultant for small start-up companies and specialty drug products. Dr. Kwong is on the Board of Directors for the Canadian Society of Pharmaceutical Scientists and is also an adjunct professor in the Department of Pharmaceutics at the University of Montreal and Department of Chemistry at Concordia University. More recently, Dr. Kwong also co-founded a start-up company, Giiant Pharma, working on delivering a colon specific PDEIV Inhibitor prodrug for the treatment of ulcerative colitis.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
Vendeur : ThriftBooks-Atlanta, AUSTELL, GA, Etats-Unis
Hardcover. Etat : Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. N° de réf. du vendeur G1118907337I3N00
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Vendeur : killarneybooks, Inagh, CLARE, Irlande
Hardcover. Etat : Very Good. 1st Edition. Hardcover, x + 252 pages, NOT ex-library. Book is clean and bright throughout with unmarked text, free of inscriptions and stamps, firmly bound. A tiny crease to the tip of upper corner of several leaves. Issued without a dust jacket. -- This book provides a practical framework for developing oral formulations during the preclinical and early clinical stages of drug discovery, the phases in which the majority of candidate compounds are evaluated and where formulation failures most frequently occur. The editor, formerly Senior Scientific Director at Merck & Co. in Basic Pharmaceutical Sciences, assembled contributors with direct experience of formulation challenges encountered in the pharmaceutical industry. The volume is organised around the progression from discovery through to early development, covering the physical and chemical characterisation of drug candidates, drug metabolism considerations, toxicology formulation requirements, and the biopharmaceutics classification system (BCS) as a tool for predicting oral absorption. Chapters address screening approaches for selecting viable formulation strategies, early stage clinical formulation development, regulatory filing requirements, and the practical considerations involved in outsourcing formulation work. Case studies drawn from industry experience illustrate specific challenges and the solutions applied to overcome them. The focus on preclinical and early development stages distinguishes this work from texts centred on late-stage commercial formulation, addressing a point in the drug development pipeline where efficient decision-making can significantly reduce attrition rates and development costs. The content is relevant to pharmaceutical scientists, formulation chemists and drug development professionals navigating the increasingly complex landscape of oral drug delivery, particularly as the proportion of poorly soluble compounds in development pipelines continues to grow. -- Contents: 1 Introduction / Elizabeth Kwong; 2 Lead Identification/Optimization / Mei Wong & Mark McAllister; 3 Oral Drug Formulation Development in Pharmaceutical Lead Selection Stage / Shayne Cox Gad; 4 Bridging End of Discovery to Regulatory Filing: Formulations for IND? and Registration?Enabling Nonclinical Studies / Evan A. Thackaberry; 5 Planning the First Clinical Trials with Clinical Manufacturing Organization (CMO) / Elizabeth Kwong & Caroline McGregor; 6 Formulation Strategies for High Dose Toxicology Studies: Case Studies / Dennis H. Leung; 7 Formulation, Analytical, and Regulatory Strategies for First?in?Human Clinical Trials / Lorenzo Capretto; Index. N° de réf. du vendeur 007161
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Vendeur : Basi6 International, Irving, TX, Etats-Unis
Etat : Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. N° de réf. du vendeur ABEOCT25-143531
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Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : New. N° de réf. du vendeur 21044413-n
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Vendeur : INDOO, Avenel, NJ, Etats-Unis
Etat : New. Brand New. N° de réf. du vendeur 9781118907337
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Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 21044413
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Vendeur : Grand Eagle Retail, Bensenville, IL, Etats-Unis
Hardcover. Etat : new. Hardcover. Detailing formulation approaches by stage of discovery to early development, this book gives a playbook of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research Features case studies to illustrate practical challenges and solutions in formulation selection Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing Detailing formulation approaches by stage of discovery to early development, this book gives a playbook of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. N° de réf. du vendeur 9781118907337
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Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 21044413
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Vendeur : Kennys Bookshop and Art Galleries Ltd., Galway, GY, Irlande
Etat : New. Detailing formulation approaches by stage of discovery to early development, this book gives a playbook of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. Editor(s): Kwong, Elizabeth. Num Pages: 272 pages. BIC Classification: TDCW. Category: (P) Professional & Vocational. Dimension: 238 x 160 x 20. Weight in Grams: 476. . 2017. 1st Edition. Hardcover. . . . . N° de réf. du vendeur V9781118907337
Quantité disponible : 15 disponible(s)
Vendeur : Ubiquity Trade, Miami, FL, Etats-Unis
Etat : New. Brand new! Please provide a physical shipping address. N° de réf. du vendeur 9781118907337
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