Usp35-Nf30

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Author :
Publisher : U.S. Pharmacopeia
ISBN 13 : 9781936424009
Total Pages : 0 pages
Book Rating : 4.4/5 (24 download)

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Book Synopsis Usp35-Nf30 by : United States Pharmacopeial Convention

Download or read book Usp35-Nf30 written by United States Pharmacopeial Convention and published by U.S. Pharmacopeia. This book was released on 2011-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).

Usp35-Nf30

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Author :
Publisher : U.S. Pharmacopeia
ISBN 13 : 9781936424009
Total Pages : 2146 pages
Book Rating : 4.4/5 (24 download)

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Book Synopsis Usp35-Nf30 by : United States Pharmacopeial Convention

Download or read book Usp35-Nf30 written by United States Pharmacopeial Convention and published by U.S. Pharmacopeia. This book was released on 2011-11 with total page 2146 pages. Available in PDF, EPUB and Kindle. Book excerpt: The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).

USP35-NF30 Spanish

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Publisher :
ISBN 13 : 9781936424030
Total Pages : pages
Book Rating : 4.4/5 (24 download)

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Book Synopsis USP35-NF30 Spanish by : United States Pharmacopeial Convention

Download or read book USP35-NF30 Spanish written by United States Pharmacopeial Convention and published by . This book was released on 2011-11-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 1 year subscription USP 2012 Print Subscription in Spanish (2012 book and two Supplements)

Pharmaceutical Analysis for Small Molecules

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Publisher : John Wiley & Sons
ISBN 13 : 1119425018
Total Pages : 256 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmaceutical Analysis for Small Molecules by : Behnam Davani

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-01 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Specification of Drug Substances and Products

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Publisher : Elsevier
ISBN 13 : 0081028253
Total Pages : 696 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Specification of Drug Substances and Products by : Christopher M. Riley

Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2020-07-23 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Federal Register

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Publisher :
ISBN 13 :
Total Pages : 452 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Federal Register by :

Download or read book Federal Register written by and published by . This book was released on 2013 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Profiles of Drug Substances, Excipients, and Related Methodology

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Publisher : Academic Press
ISBN 13 : 0124078281
Total Pages : 528 pages
Book Rating : 4.1/5 (24 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 2013-05-10 with total page 528 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. Contributions from leading authorities Informs and updates on all the latest developments in the field

Pharmaceutical Dosage Forms

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Publisher : CRC Press
ISBN 13 : 1841849774
Total Pages : 436 pages
Book Rating : 4.8/5 (418 download)

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Book Synopsis Pharmaceutical Dosage Forms by : Larry L. Augsburger

Download or read book Pharmaceutical Dosage Forms written by Larry L. Augsburger and published by CRC Press. This book was released on 2017-10-30 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence

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Publisher : John Wiley & Sons
ISBN 13 : 1119634601
Total Pages : 564 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence by : Umesh V. Banakar

Download or read book Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence written by Umesh V. Banakar and published by John Wiley & Sons. This book was released on 2022-01-19 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Dietary Chinese Herbs

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Publisher : Springer Science & Business Media
ISBN 13 : 3211994483
Total Pages : 802 pages
Book Rating : 4.2/5 (119 download)

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Book Synopsis Dietary Chinese Herbs by : Yanze Liu

Download or read book Dietary Chinese Herbs written by Yanze Liu and published by Springer Science & Business Media. This book was released on 2015-05-18 with total page 802 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work presents up-to-date information on chemical, pharmacological, clinical studies and historical uses of common dietary Chinese herbs. Authored by native experts in the field, the reader is introduced to each herb with a brief chronological review of Chinese literature on dietary herb uses, with chapters dedicated to each selected herb including color photos for each herb. In addition, Chinese characters as well as the Latin botanical name indices, and chemical structures for the known active compounds are also provided. The clear layout examines the health benefits that have been studied for centuries, including current clinical and toxicological data. A wide range of Traditional Chinese Medicine (TCM) herbs are investigated for their suitability into daily diets for maintaining general wellness or disease prevention. In the past decades, natural health products, dietary supplements, functional foods, or nutraceuticals have emerged in the West due to the increasing demand for non-pharmaceutical healthcare products. Traditional Chinese Medicine disease prevention and treatment incorporates the use of foods, and herbal medicine in an integrated manner, and thus the dietary Chinese herbs in used in TCM for thousands of years could be sources for developing new, effective, and safe ingredients to capture the rapidly expanding opportunity in the global market place.

Handbook of Formulating Dermal Applications

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Publisher : John Wiley & Sons
ISBN 13 : 1119364248
Total Pages : 704 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Handbook of Formulating Dermal Applications by : Nava Dayan

Download or read book Handbook of Formulating Dermal Applications written by Nava Dayan and published by John Wiley & Sons. This book was released on 2016-12-07 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: The conceptualization and formulation of skin care products intended for topical use is a multifaceted and evolving area of science. Formulators must account for myriad skin types, emerging opportunities for product development as well as a very temperamental retail market. Originally published as "Apply Topically" in 2013 (now out of print), this reissued detailed and comprehensive handbook offers a practical approach to the formulation chemist's day-to-day endeavors by: Addressing the innumerable challenges facing the chemist both in design and at the bench, such as formulating with/for specific properties; formulation, processing and production techniques; sensory and elegancy; stability and preservation; color cosmetics; sunscreens; Offering valuable guidance to troubleshooting issues regarding ingredient selection and interaction, regulatory concerns that must be addressed early in development, and the extrapolation of preservative systems, fragrances, stability and texture aids; Exploring the advantages and limitations of raw materials; Addressing scale-up and pilot production process and concerns; Testing and Measurements Methods. The 22 chapters written by industry experts such as Roger L. McMullen, Paul Thau, Hemi Nae, Ada Polla, Howard Epstein, Joseph Albanese, Mark Chandler, Steve Herman, Gary Kelm, Patricia Aikens, and Sam Shefer, along with many others, give the reader and user the ultimate handbook on topical product development.

Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

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Publisher : Springer Science & Business Media
ISBN 13 : 1461462967
Total Pages : 442 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products by : Terrence P. Tougas

Download or read book Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products written by Terrence P. Tougas and published by Springer Science & Business Media. This book was released on 2013-04-10 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).

Nutrient Delivery

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Publisher : Academic Press
ISBN 13 : 012804375X
Total Pages : 850 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Nutrient Delivery by : Alexandru Grumezescu

Download or read book Nutrient Delivery written by Alexandru Grumezescu and published by Academic Press. This book was released on 2016-08-12 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nutrient Delivery: Nanotechnology in the Agri-Food Industry, Volume Five, discusses the fabrication, merits, demerits, applications, and bioavailability enhancement mechanisms of various nanodelivery systems. Recent developments in various nanodelivery systems are also highlighted. Volume 5 contains twenty chapters, prepared by outstanding international researchers from Argentina, Brazil, Canada, China, Croatia, India, Iran, Ireland, México, Pakistan, Portugal, Serbia, Sri Lanka, and the United States. In recent years, the delivery of micronutrients at nanoscale has been widely studied as these systems have the potential to improve bioavailability, enable controlled release and enhance stability of food bioactives to a greater extent. The nanodelivery systems typically consist of the food bioactive compound encapsulated and stabilized in food grade ingredients such as lipids, proteins or polysaccharides with diameters ranging from 10 nm to 1000 nm. Among these, the lipid based delivery systems such as nanoemulsions, solid lipid nanoparticles, nanoliposomes and micelles are widely studied for the delivery of lipophilic bioactive compounds. These delivery vehicles improve the solubility, permeability, stability and bioavailability of the lipophilic compounds thereby enhancing their potential for oral delivery and functional food development. On the other hand, the hydrophilic bioactives are delivered through protein, polysaccharide or biopolymer based colloidal nanosystems such as hydrogels, nanogels and polymer nanoparticles. The major concern other than solubility is the intestinal permeability of the micronutrients. For instance, the delivery system for compounds with poor intestinal permeability and low solubility need to be carefully designed using suitable lipids and surfactants. Offers updated material for undergraduate and postgraduate students in food science, biotechnology, and related engineering fields Provides a valuable resource of recent scientific progress, along with most known applications of nanomaterials in the food industry for researchers, engineers, and academics Includes novel opportunities and ideas for developing or improving technologies in the food industry

Marine Biomaterials

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Publisher : Springer Nature
ISBN 13 : 9811647879
Total Pages : 453 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Marine Biomaterials by : Sougata Jana

Download or read book Marine Biomaterials written by Sougata Jana and published by Springer Nature. This book was released on 2022-02-14 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is focused on marine based biomedical carriers for delivery of therapeutics. Marine biomaterials and bio-based carriers show wide applications in pharmaceutical as well as biomedical fields for delivery of small and large molecules. Biomaterial-based composites, scaffolds or matrix systems are promising systems for controlled and prolonged release of drug in target site and control the premature release of drugs or bioactive compounds. This book discusses the targeted delivery of drugs and therapeutic applications. It also describes the use of marine biopolymers in cancer therapy. Different chapters describe the tissue engineering techniques to develop these carriers. The marine biomaterial-based systems are widely used for tissue engineering, and biomedical imaging. This book is meant for industry experts, students and researchers in the area of pharmaceutical sciences, biomedical engineering and material science and pharmacology.

Pharmaceutical Industry Practices on Genotoxic Impurities

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Publisher : CRC Press
ISBN 13 : 1439874204
Total Pages : 540 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Industry Practices on Genotoxic Impurities by : Heewon Lee

Download or read book Pharmaceutical Industry Practices on Genotoxic Impurities written by Heewon Lee and published by CRC Press. This book was released on 2014-08-29 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explains the how and why of various GTI control tactics and practices Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing Includes real-life examples of GTI control in drug substance and drug product development processes Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of—and a current framework for—GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.

Nanoengineering of Biomaterials

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Publisher : John Wiley & Sons
ISBN 13 : 3527349049
Total Pages : 1063 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Nanoengineering of Biomaterials by : Sougata Jana

Download or read book Nanoengineering of Biomaterials written by Sougata Jana and published by John Wiley & Sons. This book was released on 2022-04-18 with total page 1063 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive discussion of various types of nanoengineered biomaterials and their applications In Nanoengineering of Biomaterials: Drug Delivery & Biomedical Applications, an expert team of chemists delivers a succinct exploration of the synthesis, characterization, in-vitro and in-vivo drug molecule release, pharmacokinetic activity, pharmacodynamic activity, and the biomedical applications of several types of nanoengineered biomaterials. The editors have also included resources to highlight the most current developments in the field. The book is a collection of valuable and accessible reference sources for researchers in materials chemistry and related disciplines. It uses a functions-directed approach to using organic and inorganic source compounds that translate into biological systems as scaffolds, micelles, dendrimers, and other delivery systems. Nanoengineering of Biomaterials offers readers up-to-date chemistry and material science insights that are readily transferrable to biomedical systems. The book also includes: Thorough introductions to alginate nanoparticle delivery of therapeutics and chitosan-based nanomaterials in biological applications Comprehensive explorations of nanostructured carrageenan as a drug carrier, gellan gum nanoparticles in drug delivery, and guar-gum nanoparticles in the delivery of bioactive molecules Practical discussions of protein-based nanoparticles for drug delivery, solid lipid nanoparticles as drug carriers, and pH-responsive nanoparticles in therapy In-depth examinations of stimuli-responsive nano carriers in drug targeting Perfect for pharmaceutical chemists, materials scientists, polymer chemists, life scientists, and medicinal chemists, Nanoengineering of Biomaterials: Drug Delivery and Biomedical Applications is also an indispensable resource for biologists and bioengineers seeking a one-stop reference on the transferability of materials chemistry and nanotechnology to biomedicine.

Handbook of Polymers for Pharmaceutical Technologies, Structure and Chemistry

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 111904135X
Total Pages : 552 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Handbook of Polymers for Pharmaceutical Technologies, Structure and Chemistry by : Vijay Kumar Thakur

Download or read book Handbook of Polymers for Pharmaceutical Technologies, Structure and Chemistry written by Vijay Kumar Thakur and published by John Wiley & Sons. This book was released on 2015-06-19 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polymers are one of the most fascinating materials of the present era finding their applications in almost every aspects of life. Polymers are either directly available in nature or are chemically synthesized and used depending upon the targeted applications.Advances in polymer science and the introduction of new polymers have resulted in the significant development of polymers with unique properties. Different kinds of polymers have been and will be one of the key in several applications in many of the advanced pharmaceutical research being carried out over the globe. This 4-partset of books contains precisely referenced chapters, emphasizing different kinds of polymers with basic fundamentals and practicality for application in diverse pharmaceutical technologies. The volumes aim at explaining basics of polymers based materials from different resources and their chemistry along with practical applications which present a future direction in the pharmaceutical industry. Each volume offer deep insight into the subject being treated. Volume 1: Structure and Chemistry Volume 2: Processing and Applications Volume 3: Biodegradable Polymers Volume 4: Bioactive and Compatible Synthetic/Hybrid Polymers