Pharmaceutical dissolution testing, bioavailability, and bioequivalence : science, applications and beyond
by
 
Banakar, Umesh V., 1956- author.

Title
Pharmaceutical dissolution testing, bioavailability, and bioequivalence : science, applications and beyond

Author
Banakar, Umesh V., 1956- author.

ISBN
9781119634645
 
9781119634614

Physical Description
1 online resource.

Contents
Pharmaceutical dissolution testing: fundamentals and essential applications (an overview) -- Bioavailability and bioequivalence (BE): fundamentals and applications in drug product development -- Solubility, dissolution, permeability, and classification systems -- Understanding the mechanics of dissolution : mathematical models and simulations -- Dissolution testing methods: necessity is the mother of invention! -- Essentials of dissolution testing of pharmaceutical systems -- Dissolution/release test data (profile): requirements, analyses, and regulatory expectations -- Automation in dissolution testing: recent advances and continuing challenges -- In vitro - in vivo correlations (IVIVCS) : what makes them challenging! -- Biorelevant dissolution/release test method development for pharmaceutical dosage forms -- Bioavailability prediction software : hype or reality! -- Challenges and unique applications of IVIVC in drug development -- Dissolution testing in generic drug development : methods, requirements, and regulatory expectation/requirements -- Successful bioequivalence investigations : current challenges and possible solutions -- Beyond guidance(s) : convincing regulatory authorities through creative dissolution data interpretation -- Biosimilars : the emerging frontier of generics : role of dissolution testing -- Patentability of drug product based on dissolution data : intellectual property considerations! -- Setting up clinical therapeutics safety-based QC specifications for dissolution testing of a finished product -- Unlocking the mystery(ies) while predicting bioavailability from dissolution.

Abstract
In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety.

Local Note
John Wiley and Sons

Subject Term
Drugs -- Solubility -- Testing.
 
Médicaments -- Solubilité -- Essais.
 
Drugs -- Solubility -- Testing

Electronic Access
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119634645


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book597328-1001RS189Wiley E-Kitap Koleksiyonu