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Author :
Publisher :
ISBN 13 :
Total Pages : 426 pages
Book Rating : 4.3/5 (121 download)
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Elsevier
ISBN 13 : 0123860237
Total Pages : 560 pages
Book Rating : 4.1/5 (238 download)
Download or read book Spectrophotometry written by and published by Elsevier. This book was released on 2014-06-28 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is an essential handbook for anyone interested in performing the most accurate spectrophotometric or other optical property of materials measurements. The chapter authors were chosen from the leading experts in their respective fields and provide their wisdom and experience in measurements of reflectance, transmittance, absorptance, emittance, diffuse scattering, color, and fluorescence. The book provides the reader with the theoretical underpinning to the methods, the practical issues encountered in real measurements, and numerous examples of important applications. - Written by the leading international experts from industry, government, and academia - Written as a handbook, with in depth discussion of the topics - Focus on making the most accurate and reproducible measurements - Many practical applications and examples
Author : Shan R. Baker
Publisher : Elsevier Health Sciences
ISBN 13 : 0323262058
Total Pages : 802 pages
Book Rating : 4.3/5 (232 download)
Download or read book Local Flaps in Facial Reconstruction written by Shan R. Baker and published by Elsevier Health Sciences. This book was released on 2014-04-15 with total page 802 pages. Available in PDF, EPUB and Kindle. Book excerpt: Local Flaps in Facial Reconstruction brings you the detailed visual guidance and unmatched expertise you need to achieve the best results for the full range of facial flap procedures. Full-color clinical photographs and line drawings—along with high-quality surgical video clips—capture the latest facial reconstruction practices and effective methods like reconstruction of skin defects on the head and neck following tumor removal or trauma. Perspectives from facial plastic surgeons, dermatologists, ophthalmologists, and otolaryngologists help you take all of these considerations into account in treatment planning. Consult this title on your favorite e-reader, conduct rapid searches, and adjust font sizes for optimal readability. Make the most effective clinical decisions with a better understanding of the anatomy, physiology, and biomechanics of the skin Understand skin flap anatomy and physiology—vital to the performance of successful local flap reconstruction for facial defects. Implement the latest techniques with updated coverage of new wound closure techniques and materials (including glues and adhesives), scar revision, complications, and vascular abnormalities. Watch clips of key surgical procedures, including reconstructive surgery of the nose and lip. Avoid pitfalls and achieve the best outcomes thanks to a step-by-step approach to each procedure, complete with tips and tricks of the trade from leading experts. Minimize flap ischemia and other complications with proper preoperative planning and surgical techniques. Visualize what to look for and how to proceed with high-quality illustrations of rotation flaps, transposition flaps, advancement flaps, bilobe flaps, melolabial flaps, paramedian forehead flaps, and rhombic flaps. Access the full text, image collection, and video clips online at Expert Consult.
Author : Martin K. Childers
Publisher : Humana Press
ISBN 13 : 1493932284
Total Pages : 341 pages
Book Rating : 4.4/5 (939 download)
Download or read book Regenerative Medicine for Degenerative Muscle Diseases written by Martin K. Childers and published by Humana Press. This book was released on 2015-12-19 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book compiles and explores cutting-edge research in degenerative skeletal disorders, such as Duchenne muscular dystrophy and congenital myopathy, and new stem-cell based therapies and gene replacement therapy. Twelve expertly-authored chapters navigate the nuances of these treatments in an array of contexts and biological systems. The topics covered include: How are urine cells from a patient with Duchenne muscular dystrophy transformed into beating heart cells? What can reprogrammed cells tell us about heart muscle failure? What do gene mutations mean for those born with a muscle disease? How are manufacturing methods applied to human stem cells? Does therapeutic exercise benefit those patients who receive engineered limb muscle? Is there practical advice about nutrition to enhance muscle function for the Duchenne patient? Can microRNAs be useful to regenerate diseased muscle? Regenerative Medicine for Degenerative Muscle Diseases is ideal for scientists and clinicians from varying disciplines in genetics, cell biology, virology, cell-based manufacturing, rehabilitation medicine, nutrition, veterinary medicine and neurosurgery. The reader will see how transformative changes occur in medicine that can powerfully impact the future for patients suffering from inherited disorders affecting muscles of the body, including the heart.
Author : Ann Newman
Publisher : John Wiley & Sons
ISBN 13 : 1118455207
Total Pages : 502 pages
Book Rating : 4.1/5 (184 download)
Download or read book Pharmaceutical Amorphous Solid Dispersions written by Ann Newman and published by John Wiley & Sons. This book was released on 2015-03-09 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations • Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach • Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world
Author : Victoria Samanidou
Publisher : MDPI
ISBN 13 : 3039369245
Total Pages : 154 pages
Book Rating : 4.0/5 (393 download)
Download or read book Five Years of Separations written by Victoria Samanidou and published by MDPI. This book was released on 2021-01-21 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Five years of Separations are celebrated by a collection of ten feature articles: one review and nine research articles on topics of current interest. Applications of Gas Chromatography for the Analysis of Tricyclic Antidepressants in Biological Matrices are presented focusing on novel extraction techniques and novel materials used for sample preparation due to the great demand for method development for the determination of TCAs in biofluids, especially for therapeutic drug monitoring. Original research articles include the following: 1. Insights into the Mechanism of Separation of Bisphosphonates by Zwitterionic Hydrophilic Interaction Liquid Chromatography: Application to the Quantitation of Risedronate in Pharmaceuticals. 2. A method based on micro-matrix solid-phase dispersion (μ-MSPD) followed by gas-chromatography tandem mass spectrometry (GC–MS/MS), developed to analyze UV filters in personal care products. 3. The performance of a vibratory shear-enhanced process (VSEP) combined with an appropriate membrane unit for the treatment of simulated or industrial tannery wastewaters. 4. A method for the analysis of thyroid hormones by liquid chromatography-mass spectrometry that was used for the dissolution testing of single- and dual-component thyroid hormone supplements via a two-stage biorelevant dissolution procedure. 5. A method involving the collection and determination of organic and inorganic gunshot residues on hands using online in-tube solid-phase microextraction (IT-SPME) coupled to miniaturized capillary liquid chromatography with diode array detection (CapLC-DAD) and scanning electron microscopy coupled to energy dispersion X-ray (SEM-EDX), respectively, for quantifying both residues. 6. The gas chromatographic retention behavior of 16 polycyclic aromatic hydrocarbons (PAHs) and alkylated PAHs on a new ionic liquid stationary phase, 1,12-di(tripropylphosphonium) dodecane bis(trifluoromethanesulfonyl)imide (SLB®-ILPAH) intended for the separation of PAH mixtures, which was compared with the elution pattern on more traditional stationary phases: a non-polar phenyl arylene (DB-5ms) and a semipolar 50% phenyl dimethyl siloxane (SLB PAHms) column. 7. The Multiple-Stage Precursor Ion Separation and High Resolution Mass Spectrometry toward Structural Characterization of 2,3-Diacyltrehalose Family from Mycobacterium tuberculosis 8. The use of micellar electrokinetic chromatography (MEKC) for studying the hydrophobic character of modified Monomethyl Auristatin E derivatives, as Novel Candidates for the Design of Antibody–Drug Conjugates, which are promising state-of-the-art biopharmaceutical drugs for selective drug-delivery applications and the treatment of diseases such as cancer. 9. The use of recycled diatomaceous earth as the extraction phase in solid phase microextraction (SPME) technique for the determination of polycyclic aromatic hydrocarbons (PAHs) in river water samples, with separation/detection performed by gas chromatography-mass spectrometry (GC-MS).
Author : Alexander A. Vinks
Publisher : Springer Science & Business Media
ISBN 13 : 0387756132
Total Pages : 467 pages
Book Rating : 4.3/5 (877 download)
Download or read book Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics written by Alexander A. Vinks and published by Springer Science & Business Media. This book was released on 2013-11-23 with total page 467 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the past decade, significant progress has been made in the theory and applications of pharmacodynamics of antimicrobial agents. On the basis of pharmacokinetic-pharmacodynamic modeling concepts it has become possible to describe and predict the time course of antimicrobial effects under normal and pathophysiological conditions. The study of pharmacokinetic-pharmacodynamic relationships can be of considerable value in understanding drug action, defining optimal dosing regimens, and in making predictions under new or changing pre-clinical and clinical circumstances. Not surprisingly, pharmacokinetic-pharmacodynamic modeling concepts are increasingly applied in both basic and clinical research as well as in drug development. The book will be designed as a reference on the application of pharmacokinetic-pharmacodynamic principles for the optimization of antimicrobial therapy, namely pharmacotherapy, and infectious diseases. The reader will be introduced to various aspects of the fundamentals of antimicrobial pharmacodynamics, the integration of pharmacokinetics with pharmacodynamics for all major classes of antibiotics, and the translation of in vitro and animal model data to basic research and clinical situations in humans.
Author : Shan R. Baker
Publisher : Elsevier Health Sciences
ISBN 13 : 0323696732
Total Pages : 845 pages
Book Rating : 4.3/5 (236 download)
Download or read book Local Flaps in Facial Reconstruction E-Book written by Shan R. Baker and published by Elsevier Health Sciences. This book was released on 2021-04-03 with total page 845 pages. Available in PDF, EPUB and Kindle. Book excerpt: New clinical cases, enlarged photographs, new abstracts and algorithms, and more make the 4th Edition of Local Flaps in Facial Reconstruction your state-of-the-art resource for achieving optimal results for the full range of facial flap procedures. It offers detailed visual guidance and unmatched expertise from prominent surgeons in facial plastic surgery, ophthalmology, and dermatology, reflecting the multi-specialty nature of this dynamic field. Full-color clinical photographs and line drawings, along with high-quality surgical video clips, capture the latest, most effective facial reconstruction practices and methods. - Clearly demonstrates practical and effective methods of reconstruction of skin defects in a variety of sizes, configurations, and locations on the head and neck. - Covers the basic concepts of flap physiology, design, and mechanics of flap transfer, including multiple clinical examples for each flap; the second section describes the use of local flaps in reconstruction of individual facial structures including the auricles, lips, eyelids, cheeks, forehead, and nose. - Contains many new clinical cases, new abstracts preceding each chapter, new algorithms for selecting the preferred local flap, an updated and expanded bibliography, newer approaches to facial reconstruction, and enlarged photographs to better view flap design, planes of dissection, and methods of flap transfer. - Offers new, more complex clinical cases of nasal reconstruction, as well as updated coverage of new wound closure techniques and materials. - Includes an outstanding video library demonstrating the design, dissection, and transfer of the majority of local flaps and grafts currently in use today, accompanied by expert commentary. - Features more than 2,300 superb illustrations and photographs of rotation flaps, transposition flaps, advancement flaps, bilobe flaps, melolabial flaps, paramedian forehead flaps, rhombic flaps, and mucosal flaps.
Author : Ryan Forrey
Publisher : ASHP
ISBN 13 : 1585286508
Total Pages : 1069 pages
Book Rating : 4.5/5 (852 download)
Download or read book Compounding Sterile Preparations written by Ryan Forrey and published by ASHP. This book was released on 2023-11-13 with total page 1069 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of Compounding Sterile Preparations by Ryan A. Forrey, Lindsey B. Amerine, and Angela W. Yaniv reflects the latest advancements in the field, providing you with an indispensable resource to navigate the complex landscape of sterile compounding. New in this Edition: Updated Standards: All chapters have undergone extensive revisions to align with the most recent literature and the revised USP standards. USP Chapter : Now includes information on radiopharmaceutical compounding in USP Chapter . Expanded Knowledge Base: Two brand-new chapters covering Allergenic Extracts and Corrective and Preventative Action (CAPA) Plans.
Author : Christa Modschiedler
Publisher : American Library Association
ISBN 13 : 0838912214
Total Pages : 488 pages
Book Rating : 4.8/5 (389 download)
Download or read book Guide to Reference in Medicine and Health written by Christa Modschiedler and published by American Library Association. This book was released on 2014-04-26 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawn from the extensive database of Guide to Reference, this up-to-date resource provides an annotated list of print and electronic biomedical and health-related reference sources, including internet resources and digital image collections. Readers will find relevant research, clinical, and consumer health information resources in such areas as Medicine Psychiatry Bioethics Consumer health and health care Pharmacology and pharmaceutical sciences Dentistry Public health Medical jurisprudence International and global health Guide to Reference entries are selected and annotated by an editorial team of top reference librarians and are used internationally as a go-to source for identifying information as well as training reference professionals. Library staff answering health queries as well as library users undertaking research on their own will find this an invaluable resource.
Author : R.P. Casaroli-Marano
Publisher : Karger Medical and Scientific Publishers
ISBN 13 : 3318025852
Total Pages : 220 pages
Book Rating : 4.3/5 (18 download)
Download or read book Cell-Based Therapy for Retinal Degenerative Disease written by R.P. Casaroli-Marano and published by Karger Medical and Scientific Publishers. This book was released on 2014-04-22 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, some of the leading authorities present their exploration of applications of stem cell therapy to the treatment of major causes of blindness, including degenerative diseases and glaucoma. The diagnostic approach to patients, general concepts of cell-based therapy, immunological considerations, approaches to cell delivery (including engineered scaffolds), combined cell and gene therapy, nanomedicine applications to cell therapy and regulatory issues pertaining to manufacture and production are all considered in detail. The book serves as an excellent introduction to a field that is now entering early-stage clinical trials and promises to operate at the leading edge of regenerative medicine. Retina specialists, general ophthalmologists as well as researchers will find here a wealth of information on the translational aspects of cell-based therapies. Further, business executives and students interested in understanding the potential applications of stem cell therapy to retinal degenerative disease and glaucoma will also find this book informative reading.
Author : Gregory K. Webster
Publisher : CRC Press
ISBN 13 : 1315340860
Total Pages : 578 pages
Book Rating : 4.3/5 (153 download)
Download or read book Poorly Soluble Drugs written by Gregory K. Webster and published by CRC Press. This book was released on 2017-01-06 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.
Author : Parag Kolhe
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 590 pages
Book Rating : 4.4/5 (614 download)
Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Author : Marco A. Zarbin
Publisher : Springer
ISBN 13 : 3030052222
Total Pages : 286 pages
Book Rating : 4.0/5 (3 download)
Download or read book Cell-Based Therapy for Degenerative Retinal Disease written by Marco A. Zarbin and published by Springer. This book was released on 2019-03-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses why specific diseases are being targeted for cell-based retinal therapy, what evidence exists that justifies optimism for this approach, and what challenges must be managed in order to bring this technology from the laboratory into routine clinical practice. There are a number of unanswered questions (e.g., surgical approach to cell delivery, management of immune response, optimum cell type to transplant) that very likely are not going to be answered until human trials are undertaken, but there is a certain amount of “de-risking” that can be done with preclinical experimentation. This book is essential reading for scientists, clinicians, and advanced students in stem cell research, cell biology, and ophthalmology.
Author : Fenghe Qiu
Publisher : Academic Press
ISBN 13 : 0128027851
Total Pages : 514 pages
Book Rating : 4.1/5 (28 download)
Download or read book Accelerated Predictive Stability (APS) written by Fenghe Qiu and published by Academic Press. This book was released on 2018-05-14 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly. - Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) - Presents the scientific basis of different APS models - Includes the applications and utilities of APS that are demonstrated through numerous case studies - Covers up-to-date regulatory experience
Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425034
Total Pages : 258 pages
Book Rating : 4.1/5 (194 download)
Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-07-12 with total page 258 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.
Author : Ved Srivastava
Publisher : Royal Society of Chemistry
ISBN 13 : 1788018699
Total Pages : 572 pages
Book Rating : 4.7/5 (88 download)
Download or read book Peptide Therapeutics written by Ved Srivastava and published by Royal Society of Chemistry. This book was released on 2019-08-16 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.
