| Description |
1 online resource |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Dedication; Contents; Preface to the Series-Third Edition; Preface to the Series-Second Edition; Preface to the Series-First Edition; Preface to the Volume-First Edition; Author; Part I: Regulatory and Manufacturing Considerations; 1: Bioequivalence Testing: Rationale and Principles; I. BACKGROUND; II. EVIDENCE TO MEASURE BIOEQUIVALENCE; III. PIVOTAL PARAMETERS FOR BLOOD-LEVEL BIOEQUIVALENCE; A. Area under the Curve Estimates; IV. RATE OF ABSORPTION; V. DETERMINATION OF PRODUCT BIOEQUIVALENCE; VI. ERRORS IN BIOEQUIVALENCE STUDIES |
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VII. ABSORPTION PROFILINGVIII. PHARMACOKINETIC MEASURES OF SYSTEMIC EXPOSURE; A. Early Exposure; B. Peak Exposure; C. Total Exposure; IX. STATISTICAL ANALYSIS; X. UNTRANSFORMED DATA; XI. LOGARITHMICALLY TRANSFORMED DATA; Bibliography; Appendix: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs-General Considerations; I. Introduction; II. Background; A. General; B. Bioavailability; C. Bioequivalence; III. Methods to Document BA And BE; A. Pharmacokinetic Studies; B. Other Approaches to Support BA/BE; IV. Documenting BA And BE For Various Dosage Forms |
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A. Solutions and Other Solubilized Dosage FormsB. Immediate-Release Products; C. Modified-Release Products; D. Batch Size; B. In Vitro Studies Conducted in Support of Demonstrating BA or BE; VI. Special Topics; A. Alcoholic Beverage Effects on MR Drug Products; B. Enantiomers versus Racemates; C. Drug Products With Complex Mixtures as the Active Ingredients; D. Long-Half-Life Drugs; E. Orally Administered Drugs Intended for Local Action; F. Combination/Coadministered Drug Products; G. Endogenous Substances; H. Drug Products With High Intrasubject Variability |
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Appendix A: General Study Design and Data HandlingStudy Conduct; Sample Collection and Sampling Times; Subjects with Pre-Dose Plasma Concentrations; Data Deletion because of Vomiting; Data Submission and Analysis; Rounding Off of Confidence Interval Values; 2: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: Guidance for Industry*; I. INTRODUCTION; II. THE BIOPHARMACEUTICS CLASSIFICATION SYSTEM; A. Solubility; B. Permeability; C. Dissolution |
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III. RECOMMENDED METHODOLOGY FOR CLASSIFYING A DRUG SUBSTANCE AND FOR DETERMINING THE DISSOLUTION CHARACTERISTICS OF A DRUG PRODUCTA. Determining Drug Substance Solubility Class; B. Determining Drug Substance Permeability Class; C. Determining Drug Product Dissolution Characteristics and Dissolution Profile Similarity7; IV. BIOWAIVERS BASED ON BCS; V. ADDITIONAL CONSIDERATIONS FOR REQUESTING A BIOWAIVER; A. Excipients; B. Prodrugs; C. Fixed Dose Combinations Containing BCS Class 1, or Class 3, or a Combination of Class 1 and 3 Drugs; D. Exceptions |
| Summary |
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Sarfaraz K. Niazi, Ph. D a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines. He is Founder and Executive Chairman of Adello Biologics, LLC, (formerly, Therapeutic Proteins International, LLC), a biosimilar products company located in Chicago, IL, Piscataway, NJ and Cashel, Ireland. As an entrepreneur, Niazi has raised hundreds of millions of dollars and became recognized as an inductee into the Chicago Entrepreneur Hall of Fame. Niazi began his career teaching pharmaceutical sciences at the University of Illinois, College of Pharmacy where he was tenured before entering the industry at Abbott International. He departed Abbott as an Abbott Volwiler Fellow to pursue his passion, first through global consulting and later through the founding a biosimilar products company. A prolific inventor with scores of patents, most prominently in the field of bioprocessing technology, Niazi is currently the largest single holder of bioprocess technology patents. His other inventions span a broad category of technologies, new chemical entities, new formulations, new analytical methodologies, and much more. He has hands on experience in developing chemical, botanical and biological products, from discovery to regulatory approval. With over 50 ISBNs under his name, Niazi has authored many landmark books in the field of pharmaceutical sciences. He currently serves as Adjunct Professor at the University of Illinois College of Pharmacy, Ad Hoc faculty at the University of Houston, Texas, the HEJ Research Institute, Karachi, and the National University of Science and Technology, Islamabad. He has also served as a Foreign Professor at the HEJ Research Institute, Karachi. He serves on the editorial board of the journal MOJ Proteomics & Bioinformatics (MOJPB) and starting 2017, as Chief Editor of International Journal of Biosimilars. He also serves as Member of National Advisory Board of the College of Pharmacy, University of Illinois. He is a Fellow of the Pakistan Academy of Medical Sciences, Fellow National Academy of Clinical Biochemistry and Institute of Biology. He served as a TOKTEN Fellow to India (Transfer of Knowledge Through Expatriate Nationals (UNDP). In 2013, he received the one of the highest civilian awards, Star of Distinction in Engineering, from the Pakistani President. He has hosted a radio show at Voice of America (US State Department) on a weekly basis for more than 5 years with audience into billions |
| Subject |
Drugs -- Dosage forms -- Handbooks, manuals, etc
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MEDICAL -- Pharmacology.
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Drugs -- Dosage forms.
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| Genre/Form |
Handbooks and manuals.
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| Form |
Electronic book
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| ISBN |
9781351594912 |
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1351594915 |
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9781315103389 |
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1315103389 |
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9781351594905 |
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1351594907 |
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9781351594899 |
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1351594893 |
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