Screen LibraryPharmaceutical dissolution testing, bioavailability, and bioequivalence : science, applications and beyond /
Saved in:
| Main Authors: | |
|---|---|
| Published: |
Wiley,
|
| Publisher Address: | Hoboken, NJ : |
| Publication Dates: | 2022. |
| Literature type: | Book |
| Language: | English |
| Subjects: | |
| Carrier Form: | xxviii, 532 pages : illustrations, forms ; 24 cm |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: |
9781119634607 1119634601 |
| Index Number: | RS189 |
| CLC: | R917 |
| Call Number: | R917/B212 |
| 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. |