Oral formulation roadmap from early drug discovery to development
by
 
Kwong, Elizabeth, 1954- editor.

Title
Oral formulation roadmap from early drug discovery to development

Author
Kwong, Elizabeth, 1954- editor.

ISBN
9781118907894
 
9781118907870
 
9781118908020
 
9781118907955

Physical Description
1 online resource (x, 252 pages)

Contents
Introduction / Elizabeth Kwong -- Lead identification/optimization / Dr. Mei Wong And Dr. Mark Mcallister -- Oral drug formulation development in pharmaceutical lead selection stage / Shayne Cox Gad -- Bridging end of discovery to regulatory filing : formulations for IND- and registration-enabling nonclinical studies / Evan A. Thackaberry -- Planning the first clinical trials with clinical manufacturing organization (CMO) / Elizabeth Kwong and Caroline McGregor -- Formulation strategies for high dose toxicology studies : case studies / Dennis H. Leung, Pierre Daublain, Mengwei Hu, Kung-I Feng -- Formulation, analytical and regulatory strategies for first in human clinical trials / Lorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden, and Steven Booth.

Abstract
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.

Local Note
John Wiley and Sons

Subject Term
Drug development.
 
Drugs -- Dosage forms.
 
Drug Discovery
 
Chemistry, Pharmaceutical -- methods
 
Clinical Trials as Topic
 
Dosage Forms
 
Administratoin, Oral
 
Médicaments -- Développement.
 
Médicaments -- Formes pharmaceutiques.
 
MEDICAL -- Pharmacology.
 
Pharmacology.
 
Biochemistry.
 
MEDICAL.
 
Analytic.
 
Chemistry.
 
SCIENCE.
 
Drugs -- Dosage forms
 
Drug development

Genre
Electronic books.
 
Internet Resources.

Added Author
Kwong, Elizabeth, 1954-

Electronic Access
https://onlinelibrary.wiley.com/doi/book/10.1002/9781118907894


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book593258-1001RS420 .O73 2017 EBWiley E-Kitap Koleksiyonu