Analytical Profiles of Drug Substances and Excipients

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Publisher : Academic Press
ISBN 13 : 9780080861197
Total Pages : 619 pages
Book Rating : 4.8/5 (611 download)

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Book Synopsis Analytical Profiles of Drug Substances and Excipients by :

Download or read book Analytical Profiles of Drug Substances and Excipients written by and published by Academic Press. This book was released on 1996-08-30 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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Author :
Publisher : Academic Press
ISBN 13 : 0123877024
Total Pages : 398 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Profiles of Drug Substances, Excipients and Related Methodology by : Harry G. Brittain

Download or read book Profiles of Drug Substances, Excipients and Related Methodology written by Harry G. Brittain and published by Academic Press. This book was released on 2011-07-15 with total page 398 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (38 download)

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Book Synopsis Analytical Profiles of Drug Substances by :

Download or read book Analytical Profiles of Drug Substances written by and published by . This book was released on 1972 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Analytical Profiles of Drug Substances and Excipients

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Author :
Publisher : Academic Press
ISBN 13 : 9780080861227
Total Pages : 388 pages
Book Rating : 4.8/5 (612 download)

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Book Synopsis Analytical Profiles of Drug Substances and Excipients by :

Download or read book Analytical Profiles of Drug Substances and Excipients written by and published by Academic Press. This book was released on 2001-03-19 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 American Association of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together in 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

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Publisher : Academic Press
ISBN 13 : 0323854834
Total Pages : 400 pages
Book Rating : 4.3/5 (238 download)

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Book Synopsis Profiles of Drug Substances, Excipients, and Related Methodology by : Abdulrahman Al-Majed

Download or read book Profiles of Drug Substances, Excipients, and Related Methodology written by Abdulrahman Al-Majed and published by Academic Press. This book was released on 2022-04-06 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Profiles of Drug Substances, Excipients and Related Methodology

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Author :
Publisher : Academic Press
ISBN 13 : 9780080861104
Total Pages : 795 pages
Book Rating : 4.8/5 (611 download)

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Book Synopsis Profiles of Drug Substances, Excipients and Related Methodology by :

Download or read book Profiles of Drug Substances, Excipients and Related Methodology written by and published by Academic Press. This book was released on 1986-09-10 with total page 795 pages. Available in PDF, EPUB and Kindle. Book excerpt: Profiles of Drug Substances, Excipients and Related Methodology

Analytical Profiles of Drug Substances

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Publisher : Academic Press
ISBN 13 : 0122608178
Total Pages : 814 pages
Book Rating : 4.1/5 (226 download)

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Book Synopsis Analytical Profiles of Drug Substances by : Klaus Florey

Download or read book Analytical Profiles of Drug Substances written by Klaus Florey and published by Academic Press. This book was released on 1988 with total page 814 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although the official compendia define a drug substance as to identity, purit strength, and quality, they normally do not provide other physical or chemic data, nor do they list methods of synthesis or pathways of physical or biological degradation and metablism. This is the 17th annual volume to p

Analytical Profiles of Drug Substances

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Publisher :
ISBN 13 : 9780122608124
Total Pages : 735 pages
Book Rating : 4.6/5 (81 download)

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Book Synopsis Analytical Profiles of Drug Substances by : Klaus Florey

Download or read book Analytical Profiles of Drug Substances written by Klaus Florey and published by . This book was released on 1983 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Analytical Profiles of Drug Substances

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Publisher :
ISBN 13 : 9780122608193
Total Pages : 666 pages
Book Rating : 4.6/5 (81 download)

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Book Synopsis Analytical Profiles of Drug Substances by : Klaus Florey

Download or read book Analytical Profiles of Drug Substances written by Klaus Florey and published by . This book was released on 1990 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Excipient Applications in Formulation Design and Drug Delivery

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Publisher : Springer
ISBN 13 : 3319202065
Total Pages : 681 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Excipient Applications in Formulation Design and Drug Delivery by : Ajit S Narang

Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 681 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Prof. of Drug Substances, Excipients and Related Methodology

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Publisher : Academic Press
ISBN 13 : 0128241276
Total Pages : 326 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Prof. of Drug Substances, Excipients and Related Methodology by : Abdulrahman Al-Majed

Download or read book Prof. of Drug Substances, Excipients and Related Methodology written by Abdulrahman Al-Majed and published by Academic Press. This book was released on 2021-01-30 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Peptide Therapeutics

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Publisher : Royal Society of Chemistry
ISBN 13 : 1788014332
Total Pages : 572 pages
Book Rating : 4.7/5 (88 download)

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Book Synopsis Peptide Therapeutics by : Ved Srivastava

Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-28 with total page 572 pages. Available in PDF, EPUB and Kindle. Book excerpt: Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.

Countering the Problem of Falsified and Substandard Drugs

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Publisher : National Academies Press
ISBN 13 : 0309269393
Total Pages : 377 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine

Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Formulation and Analytical Development for Low-Dose Oral Drug Products

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0470056096
Total Pages : 506 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Formulation and Analytical Development for Low-Dose Oral Drug Products by : Jack Zheng

Download or read book Formulation and Analytical Development for Low-Dose Oral Drug Products written by Jack Zheng and published by John Wiley & Sons. This book was released on 2009-02-09 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Profiles of Drug Substances, Excipients and Related Methodology

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Author :
Publisher : Elsevier
ISBN 13 : 9780080555966
Total Pages : 740 pages
Book Rating : 4.5/5 (559 download)

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Book Synopsis Profiles of Drug Substances, Excipients and Related Methodology by : Harry G. Brittain

Download or read book Profiles of Drug Substances, Excipients and Related Methodology written by Harry G. Brittain and published by Elsevier. This book was released on 2007-11-14 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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; 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 * Now encompassing critical review chapters * Meets the information needs of the drug development community

Analytical Techniques in the Pharmaceutical Sciences

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Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 838 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz

Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Analytical Profiles Of Drug Substances

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Publisher :
ISBN 13 : 9788181477699
Total Pages : pages
Book Rating : 4.4/5 (776 download)

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Book Synopsis Analytical Profiles Of Drug Substances by : Florey Klaus

Download or read book Analytical Profiles Of Drug Substances written by Florey Klaus and published by . This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: