Dissolution Bioavailability Bioequivalence
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| Author | : Hamed Mahmmoud Abdou |
| Publisher | : Mack Publishing Company |
| Total Pages | : 594 |
| Release | : 1989 |
| Genre | : Science |
| ISBN | : |
1. Evolution of dissolution testing 5; 2. Theory of dissolution 11; 3. Theoretical concepts for the release of a drug from dosage forms 37; 4. Effect of the physicochemical properties of the drug on dissolution rate 53; 5. Factors affecting the rate of dissolution of solid dosage forms 73; 6. Effects of storage and packaging on the dissolution of drug formulations 107; 7. Factors relating to the dissolution apparatus 115; 8. Effect of the test parameters on dissolution rate 145; 9. Dissolution of suspensions 173; 10. Dissolution of topical dosage forms (creams, gels, and ointments) 189; 11. Dissolutions of suppositories 205; 12. Dissolution characteristics of controlled-release systems 215; 13. Methods for enhancement of the drug-dissolution characteristics 265; 14. Developing a new dissolution method 285; 15. Bioavailability, definitions and historical perspective 297; 17. In vitro modeling for drug absorption 315; 18. Pharmacokinetic considerations in bioavailability studies 335; 19. Bioavailability and variations in drug blood levels 367; 20. Bioavailability and the biologic response 385; 21. Measurements of bioavailability 399; 22. General issues to be considered in conducting bioavailability studies 415; 23. Bioavailability of controlled-release dosage forms 425; 24. In vivo release and bioavailability of topical preparations 437; 25. Methods for enhancement of bioavailability 455; 26. Bioequivalence: general definitions 477; 27. Bioequivalence: case histories 481; 28. Correlation of in vitro rate of dissolution with in vivo bioavailability 491; 29. Determination of bioequivalence and its regulatory aspects 517; 30. The official bioequivalence protocols and therapeutic equivalence 533.
| Author | : Umesh V. Banakar |
| Publisher | : John Wiley & Sons |
| Total Pages | : 564 |
| Release | : 2022-01-19 |
| Genre | : Medical |
| ISBN | : 1119634601 |
Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource 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. This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes: A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence Practical discussions about solubility, dissolution, permeability, and classification systems in drug development In-depth examinations of the mechanics of dissolution, including mathematical models and simulations An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.
| Author | : Umesh V. Banakar |
| Publisher | : CRC Press |
| Total Pages | : 456 |
| Release | : 1991-09-25 |
| Genre | : Medical |
| ISBN | : 9780824785673 |
Introduction, Historical Highlights, and the Need for Dissolution Testing Theories of Dissolution Dissolution Testing Devices Automation in Dissolution Testing, by William A. Hanson and Albertha M. Paul Factors That Influence Dissolution Testing Interpretation of Dissolution Rate Data Techniques and of In Vivo Dissolution, by Umesh V. Banakar, Chetan D. Lathia, and John H. Wood Dissolution of Dosage Forms Dissolution of Modified-Release Dosage Forms Dissolution and Bioavailability Dissolution Testing and the Assessment of Bioavailability/Bioequivalence, by Santosh J. Vetticaden Dissolution Rediscovered, by John H. Wood Appendix: USP/NF Dissolution Test.
| Author | : David B. Young |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 299 |
| Release | : 2013-03-08 |
| Genre | : Medical |
| ISBN | : 1468460366 |
This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
| Author | : Shein-Chung Chow |
| Publisher | : CRC Press |
| Total Pages | : 758 |
| Release | : 2008-10-15 |
| Genre | : Mathematics |
| ISBN | : 1420011677 |
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
| Author | : Leon Shargel |
| Publisher | : CRC Press |
| Total Pages | : 384 |
| Release | : 2013-10-24 |
| Genre | : Medical |
| ISBN | : 1420086367 |
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
| Author | : Jennifer B. Dressman |
| Publisher | : CRC Press |
| Total Pages | : 432 |
| Release | : 2016-04-19 |
| Genre | : Medical |
| ISBN | : 1420077341 |
Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
| Author | : Leon Shargel |
| Publisher | : McGraw-Hill/Appleton & Lange |
| Total Pages | : 625 |
| Release | : 1993 |
| Genre | : Biopharmaceutics |
| ISBN | : 9780838502396 |
| Author | : Isadore Kanfer |
| Publisher | : Springer |
| Total Pages | : 348 |
| Release | : 2017-12-05 |
| Genre | : Medical |
| ISBN | : 3319680781 |
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
| Author | : Sarfaraz K. Niazi |
| Publisher | : CRC Press |
| Total Pages | : 0 |
| Release | : 2007-08-22 |
| Genre | : Medical |
| ISBN | : 9780849303951 |
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies
