Profiles of Drug Substances, Excipients and Related Methodology

Author: Harry G. Brittain

Publisher: Academic Press

ISBN: 0123808855

Category: Medical

Page: 408

View: 721

Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. Presents comprehensive reviews covering all aspects of drug development and formulation of drugs Profiles creatine monohydrate and fexofenadine hydrochloride, as well as five others Meets the information needs of the drug development community
Analytical Profiles of Drug Substances

Author: Klaus Florey

Publisher:

ISBN: 0122608194

Category: Drugs

Page: 666

View: 729

Intended for medicinal, pharmaceutical and analytical chemists, this book brings together information detailing physical and chemical data defining a drug, and various methods of synthesis of biological/physical degradation and metabolism.
Analytical Profiles of Drug Substances and Excipients

Author: Harry G. Brittain

Publisher: Academic Press

ISBN: 9780080861241

Category: Medical

Page: 336

View: 821

Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Analytical Profiles of Drug Substances and Excipients brings the latest information together in one source. Represents a very important contribution to the practice of pharmaceutical analysis Presents an excellent overview of physical, chemical, and biomedical properties of some regularly prescribed drugs Each volume in the series contains a cumulative index
Analytical Profiles of Drug Substances and Excipients

Author:

Publisher: Academic Press

ISBN: 0080861180

Category: Medical

Page: 611

View: 710

Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the AmericanAssociation of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.
Profiles of Drug Substances, Excipients and Related Methodology

Author: Harry G. Brittain

Publisher: Academic Press

ISBN: 9780122608315

Category: Medical

Page: 349

View: 696

Whilst following in the footsteps of previous volumes by presenting comprehensive reviews of drug substances and additional materials, this title also heralds a significant expansion of the scope of the series. Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. This change is required to better meet the needs of the pharmaceutical communtiy and to allow the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series will encompass review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodologoy related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. Presents comprehensive reviews covering all aspects of drug development and formulation of drugs Now encompassing critical review chapters Meets the information needs of the drug development community
Pharmaceutical Stress Testing

Author: Steven W. Baertschi

Publisher: CRC Press

ISBN: 9781439801802

Category: Medical

Page: 612

View: 595

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).
Prof. of Drug Substances, Excipients and Related Methodology

Author: Abdulrahman Al-Majed

Publisher: Academic Press

ISBN: 9780128241288

Category: Medical

Page: 326

View: 863

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 46 contains comprehensive profiles of five drug compounds: Darunavir, Bisoprolol, Betaxolol, Rabeprazole and Irbesartan. In addition, the work contains a chapter reviewing Bioassay Methods and Their Applications in Herbal Drug Research. The comprehensive reviews in the book cover all aspects of drug development and the formulation of drugs, helping readers understand how the drug development community remains essential to all phases of pharmaceutical development. In addition, this work answers why such profiles are of immeasurable importance to workers in the field. The scope of the Profiles series encompasses review articles and database compilations that fall within one or more of the following five broad categories: Physical Profiles of Drug Substances and Excipients, Analytical Profiles of Drug Substances and Excipients, ADME Profiles of Drug Substances and Excipients, Methodology Related to the Characterization of Drug Substances and Excipients, and Methods of Chemical Synthesis. Contains contributions from leading authorities Presents an excellent overview on the physical, chemical and biomedical properties of some regularly prescribed drugs Includes a cumulative index in each volume
Profiles of Drug Substances, Excipients, and Related Methodology

Author: Abdulrahman Al-Majed

Publisher: Academic Press

ISBN: 9780323854832

Category: Science

Page: 398

View: 153

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 47 covers all aspects of drug development and formulation of drugs, meeting the information needs of the drug development community that are essential to all phases of pharmaceutical development. This updated release includes comprehensive profiles of five drug compounds: Vinpocetine; Loratadine; Ticagrelor; Lodenafil; Danazol. The volume also contains a chapter reviewing “Application of Chemometrics using direct Spectroscopic methods as a QC tool in Pharmaceutical Industry and their Validation. Contains contributions from leading authorities Presents an excellent overview of the physical, chemical and biomedical properties of regularly prescribed drugs Contains a cumulative index for easy access to information