{"product_id":"oral-formulation-roadmap-from-early-drug-discovery-to-development-isbn-9781118907337","title":"Oral Formulation Roadmap from Early Drug Discovery to Development","description":"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. \u003cbr\u003e\u003cbr\u003e•    Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry\u003cbr\u003e•    Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research\u003cbr\u003e•    Features case studies to illustrate practical challenges and solutions in formulation selection\u003cbr\u003e•    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 \u003cp\u003eList of Contributors vii\u003c\/p\u003e \u003cp\u003ePreface ix\u003c\/p\u003e \u003cp\u003e1 Introduction 1\u003cbr\u003e\u003ci\u003eElizabeth Kwong\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Lead Identification\/Optimization 9\u003cbr\u003e\u003ci\u003eMei Wong and Mark McAllister\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Oral Drug Formulation Development in Pharmaceutical Lead Selection Stage 39\u003cbr\u003e\u003ci\u003eShayne Cox Gad\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Bridging End of Discovery to Regulatory Filing: Formulations for IND-and Registration-Enabling Nonclinical Studies 89\u003cbr\u003e\u003ci\u003eEvan A. Thackaberry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Planning the First Clinical Trials with Clinical Manufacturing Organization (CMO) 115\u003cbr\u003e\u003ci\u003eElizabeth Kwong and Caroline McGregor\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Formulation Strategies for High Dose Toxicology Studies: Case Studies 139\u003cbr\u003e\u003ci\u003eDennis H. Leung, Pierre Daublain, Mengwei Hu and Kung]I Feng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Formulation, Analytical, and Regulatory Strategies for First-in-Human Clinical Trials 165\u003cbr\u003e\u003ci\u003eLorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden and Steven Booth\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 243\u003c\/p\u003e \u003cp\u003e\u003cb\u003eElizabeth Kwong, PhD,\u003c\/b\u003e retired from Merck \u0026amp; 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.\u003c\/p\u003e \u003cp\u003eMany of the challenges facing drug discovery and development stem from a failure to properly identify formulations that translate from preclinical to clinical phases. Further, a lack of collaboration and proper integration between formulation and discovery scientists contribute significantly to most failures in the clinic. Lastly, the regulatory requirements for formulations also increase the timelines and costs of bringing a drug candidate forward.\u003c\/p\u003e \u003cp\u003eWritten to address these many challenges and issues, this book describes and explains the key factors that help determine the types of formulation needed throughout the stages of drug discovery. Detailing formulation approaches by stage of discovery to early development, \u003ci\u003eOral Formulation Roadmap from Early Drug Discovery to Development\u003c\/i\u003e gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development.\u003c\/p\u003e \u003cp\u003eA key reference for practicing pharmaceutical scientists, this book provides a valuable resource that:\u003c\/p\u003e \u003cp\u003e•          Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry\u003c\/p\u003e \u003cp\u003e•          Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research\u003c\/p\u003e \u003cp\u003e•          Features case studies to illustrate practical challenges and solutions\u003c\/p\u003e •          Covers regulatory filing, drug metabolism and properties, biopharmaceutics classification system (BCS), screening approaches, toxicology studies, clinical formulation development, and outsourcing","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989725004005,"sku":"NP9781118907337","price":167.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118907337.jpg?v=1761785259","url":"https:\/\/k12savings.com\/es\/products\/oral-formulation-roadmap-from-early-drug-discovery-to-development-isbn-9781118907337","provider":"K12savings","version":"1.0","type":"link"}