Handbook of Drug Metabolism Third Edition

Handbook of Drug Metabolism  Third Edition
Author: Paul G. Pearson,Larry C. Wienkers
Publsiher: CRC Press
Total Pages: 750
Release: 2019-05-20
ISBN: 1482262045
Category: Medical
Language: EN, FR, DE, ES & NL

Handbook of Drug Metabolism Third Edition Book Excerpt:

This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.

Filtration and Purification in the Biopharmaceutical Industry Third Edition

Filtration and Purification in the Biopharmaceutical Industry  Third Edition
Author: Maik W. Jornitz
Publsiher: CRC Press
Total Pages: 672
Release: 2019-06-26
ISBN: 1351675699
Category: Business & Economics
Language: EN, FR, DE, ES & NL

Filtration and Purification in the Biopharmaceutical Industry Third Edition Book Excerpt:

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Information Resources in Toxicology

Information Resources in Toxicology
Author: Steve Gilbert,Asish Mohapatra,Sol Bobst,Antoinette Hayes,Sara T. Humes
Publsiher: Academic Press
Total Pages: 1054
Release: 2020-05-16
ISBN: 0128137258
Category: Medical
Language: EN, FR, DE, ES & NL

Information Resources in Toxicology Book Excerpt:

This new fifth edition of Information Resources in Toxicology offers a consolidated entry portal for the study, research, and practice of toxicology. Both volumes represents a unique, wide-ranging, curated, international, annotated bibliography, and directory of major resources in toxicology and allied fields such as environmental and occupational health, chemical safety, and risk assessment. The editors and authors are among the leaders of the profession sharing their cumulative wisdom in toxicology’s subdisciplines. This edition keeps pace with the digital world in directing and linking readers to relevant websites and other online tools. Due to the increasing size of the hardcopy publication, the current edition has been divided into two volumes to make it easier to handle and consult. Volume 1: Background, Resources, and Tools, arranged in 5 parts, begins with chapters on the science of toxicology, its history, and informatics framework in Part 1. Part 2 continues with chapters organized by more specific subject such as cancer, clinical toxicology, genetic toxicology, etc. The categorization of chapters by resource format, for example, journals and newsletters, technical reports, organizations constitutes Part 3. Part 4 further considers toxicology’s presence via the Internet, databases, and software tools. Among the miscellaneous topics in the concluding Part 5 are laws and regulations, professional education, grants and funding, and patents. Volume 2: The Global Arena offers contributed chapters focusing on the toxicology contributions of over 40 countries, followed by a glossary of toxicological terms and an appendix of popular quotations related to the field. The book, offered in both print and electronic formats, is carefully structured, indexed, and cross-referenced to enable users to easily find answers to their questions or serendipitously locate useful knowledge they were not originally aware they needed. Among the many timely topics receiving increased emphasis are disaster preparedness, nanotechnology, -omics, risk assessment, societal implications such as ethics and the precautionary principle, climate change, and children’s environmental health. Introductory chapters provide a backdrop to the science of toxicology, its history, the origin and status of toxicoinformatics, and starting points for identifying resources. Offers an extensive array of chapters organized by subject, each highlighting resources such as journals, databases,organizations, and review articles. Includes chapters with an emphasis on format such as government reports, general interest publications, blogs, and audiovisuals. Explores recent internet trends, web-based databases, and software tools in a section on the online environment. Concludes with a miscellany of special topics such as laws and regulations, chemical hazard communication resources, careers and professional education, K-12 resources, funding, poison control centers, and patents. Paired with Volume Two, which focuses on global resources, this set offers the most comprehensive compendium of print, digital, and organizational resources in the toxicological sciences with over 120 chapters contributions by experts and leaders in the field.

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
Author: Dilip M. Parikh
Publsiher: CRC Press
Total Pages: 904
Release: 2021-05-12
ISBN: 1000366383
Category: Medical
Language: EN, FR, DE, ES & NL

Handbook of Pharmaceutical Granulation Technology Book Excerpt:

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource. Key Features: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Handbook of Toxicology Third Edition

Handbook of Toxicology  Third Edition
Author: Michael J. Derelanko,Carol S. Auletta
Publsiher: CRC Press
Total Pages: 1027
Release: 2014-03-07
ISBN: 1439890137
Category: Law
Language: EN, FR, DE, ES & NL

Handbook of Toxicology Third Edition Book Excerpt:

The Handbook of Toxicology, Third Edition provides an updated practical reference source for practicing toxicologists in the pharmaceutical and chemical industries, contract laboratories, regulatory agencies, and academia. Written by experts in their specific toxicology fields, the chapters provide both fundamental and applied information. Topics range from General Toxicology, to Genetic Toxicology, Human Clinical Toxicology, Histopathology, Clinical Pathology, Metabolism and Toxicokinetics, Risk Assessment, and more. New to this edition: Completely rewritten chapters covering immunotoxicology, endocrine toxicology, and reproductive and developmental toxicology, providing a fresh perspective on these topics Addition of new chapters on Chemical Toxicology, Pharmaceutical Toxicology, Juvenile Toxicology, and Safety Pharmacology Updated information dealing with Inhalation Toxicology, Neurotoxicology, and Regulatory Toxicology, which has been consolidated into single chapters for each specialty A separate glossary with toxicological terms presented both alphabetically and by toxicological subspecialty For nearly 20 years, this handbook has remained the only reference book of its kind, designed to facilitate easy access to information related to the various toxicology specialties. This updated edition of a popular reference book reflects current practices and the state of the science of toxicology.

Biotechnology

Biotechnology
Author: Ronald P. Evens
Publsiher: CRC Press
Total Pages: 182
Release: 2020-06-04
ISBN: 0429678681
Category: Medical
Language: EN, FR, DE, ES & NL

Biotechnology Book Excerpt:

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

Applications of Pharmacokinetic Principles in Drug Development

Applications of Pharmacokinetic Principles in Drug Development
Author: Rajesh Krishna
Publsiher: Springer Science & Business Media
Total Pages: 550
Release: 2012-12-06
ISBN: 1441992162
Category: Medical
Language: EN, FR, DE, ES & NL

Applications of Pharmacokinetic Principles in Drug Development Book Excerpt:

This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.

Gene Delivery

Gene Delivery
Author: Yashwant Pathak
Publsiher: CRC Press
Total Pages: 246
Release: 2022-06-29
ISBN: 1000594793
Category: Medical
Language: EN, FR, DE, ES & NL

Gene Delivery Book Excerpt:

Gene delivery is a transport of genes of therapeutic values into the chromosomes of the cells or tissues which can be targeted to replace the faulty genes. In last two decades lot of research efforts are dedicated to gene delivery for therapeutic applications. Today gene therapy is promising approach in treatment of genetic diseases including mitochondrial related diseases like blindness, muscular dystrophy, cystic fibrosis, and some cancers. Gene Delivery Systems: Nano Delivery Technologies observes the exploration of nanotechnology for gene therapy and gene delivery. Written by prominent authors in the field, this book covers various aspects of gene delivery including challenges in delivering gene therapy, advances in genome editing, RNA-based gene therapy, Green nanoparticles for oligonucleotide delivery. Additional features include" Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Includes knowledge of the current application of CRISPR/Cas9 gene-editing technique; an approach that has recently been given the Noble Prize. Examines the development of mRNA vaccines for Covid -19 in challenging pandemic scenario Discusses siRNA, mRNA, and DNA plasmids.

Percutaneous Absorption

Percutaneous Absorption
Author: Nina Dragićević,Howard Maibach
Publsiher: CRC Press
Total Pages: 1008
Release: 2021-07-30
ISBN: 0429511566
Category: Medical
Language: EN, FR, DE, ES & NL

Percutaneous Absorption Book Excerpt:

Updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods, Fifth Edition supplies new chapters on topics currently impacting the field including cutaneous metabolism, skin contamination, exposure to protein allergens, in vitro absorption methodology and the percutaneous absorption of chemical mixtures. Complete with studies on the role of the skin as a key portal of entry for chemicals into the body, this book serves as a detailed reference source for recent advances in the field, as well as an experimental guide for laboratory personnel. Key Features: Details in vivo and in vitro methods for measuring absorption, dermal decontamination, mechanisms of transdermal delivery, and the relationship of transepidermal water loss to percutaneous absorption Considers a range of mathematical models, the safety evaluation of cosmetic ingredients, the absorption of hair dyes, nanoparticles for drug delivery, and other novel methods of drug delivery Discusses topics including skin metabolism, the skin reservoir, and the effects of desquamation on absorption

Handbook of Drug Screening

Handbook of Drug Screening
Author: Ramakrishna Seethala,Litao Zhang
Publsiher: CRC Press
Total Pages: 504
Release: 2016-04-19
ISBN: 1420061690
Category: Medical
Language: EN, FR, DE, ES & NL

Handbook of Drug Screening Book Excerpt:

Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery. With extensively updated content and 21 new chapters, this text examines:quality and efficiency of drug target validati

Identification and Quantification of Drugs Metabolites Drug Metabolizing Enzymes and Transporters

Identification and Quantification of Drugs  Metabolites  Drug Metabolizing Enzymes  and Transporters
Author: Shuguang Ma,Swapan Chowdhury
Publsiher: Elsevier
Total Pages: 708
Release: 2020-07-09
ISBN: 0128200197
Category: Science
Language: EN, FR, DE, ES & NL

Identification and Quantification of Drugs Metabolites Drug Metabolizing Enzymes and Transporters Book Excerpt:

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade’s numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics All chapters are written by experts with a wide range of practical experience from the industry and academia

Handbook of Medicine in Psychiatry Third Edition

Handbook of Medicine in Psychiatry  Third Edition
Author: Peter Manu, M.D.,Corey Karlin-Zysman, M.D.,Eugene Grudnikoff, M.D.
Publsiher: American Psychiatric Pub
Total Pages: 550
Release: 2020-03-11
ISBN: 1615372288
Category: Medical
Language: EN, FR, DE, ES & NL

Handbook of Medicine in Psychiatry Third Edition Book Excerpt:

This updated, third edition has been streamlined to provide a pragmatic approach to the realities confronting clinicians in today's busy inpatient and outpatient psychiatric settings. Each chapter features one or more clinical vignettes that illustrate the complexity of the presentation of abnormal vital signs and somatic disorders in psychiatri

Generic Drug Product Development

Generic Drug Product Development
Author: Isadore Kanfer,Leon Shargel
Publsiher: CRC Press
Total Pages: 332
Release: 2016-04-19
ISBN: 1420020021
Category: Medical
Language: EN, FR, DE, ES & NL

Generic Drug Product Development Book Excerpt:

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Handbook of Statistics in Clinical Oncology Third Edition

Handbook of Statistics in Clinical Oncology  Third Edition
Author: John Crowley,Antje Hoering
Publsiher: CRC Press
Total Pages: 661
Release: 2012-03-26
ISBN: 1439862001
Category: Mathematics
Language: EN, FR, DE, ES & NL

Handbook of Statistics in Clinical Oncology Third Edition Book Excerpt:

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients
Author: Stanley Nusim
Publsiher: CRC Press
Total Pages: 456
Release: 2016-04-19
ISBN: 1439803390
Category: Medical
Language: EN, FR, DE, ES & NL

Active Pharmaceutical Ingredients Book Excerpt:

To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. Topics include:Safety, efficacy, and envi

Generic Drug Product Development

Generic Drug Product Development
Author: Leon Shargel,Isadore Kanfer
Publsiher: CRC Press
Total Pages: 288
Release: 2016-04-19
ISBN: 142002003X
Category: Medical
Language: EN, FR, DE, ES & NL

Generic Drug Product Development Book Excerpt:

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Principles of Biochemical Toxicology Third Edition

Principles of Biochemical Toxicology  Third Edition
Author: John Timbrell
Publsiher: CRC Press
Total Pages: 404
Release: 1999-10-21
ISBN: 0748407367
Category: Medical
Language: EN, FR, DE, ES & NL

Principles of Biochemical Toxicology Third Edition Book Excerpt:

Research into the biochemical basis of toxicology has expanded rapidly over recent years, amidst concerns over the adverse effects of drugs, environmental pollution and occupational hazards. Following on from the acclaimed first two editions of Principles of Biochemical Toxicology, John Timbrell has expanded the text to include: summary sections questions and model answers thoroughly revised artwork These features, plus the new easy-to-read format will make biochemical toxicology more accessible to undergraduates and postgraduates coming across the subject for the first time, particularly when undertaking self-directed study. This comprehensive textbook provides a thorough explanation of dose-response relationships; disposition and metabolism; toxic responses to foreign compounds, and detailed examples to illustrate mechanisms of toxicity. There is also an expanded and updated bibliography, directing the reader to further reading if required. Students and lecturers will find the clear and concise approach, which established this book as the leading textbook in its field, an essential aid to learning and teaching.

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
Author: Mark Gibson
Publsiher: CRC Press
Total Pages: 560
Release: 2016-04-19
ISBN: 1420073184
Category: Medical
Language: EN, FR, DE, ES & NL

Pharmaceutical Preformulation and Formulation Book Excerpt:

Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.

Modern Pharmaceutics Volume 1

Modern Pharmaceutics Volume 1
Author: Alexander T. Florence,Juergen Siepmann
Publsiher: CRC Press
Total Pages: 656
Release: 2009-05-28
ISBN: 1420065653
Category: Medical
Language: EN, FR, DE, ES & NL

Modern Pharmaceutics Volume 1 Book Excerpt:

With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics. Key topics in Volume 1 include: • principles of drug absorption, chemical kinetics, and drug stability • pharmacokinetics • the effect of route of administration and distribution on drug action • in vivo imaging of dose forms: gamma scintigraphy, PET imaging NMR, MRI, etc. • powder technology • excipient design and characterization • preformulation • optimization techniques in pharmaceutical formulation and processing • disperse and surfactant systems • the solid state, tablet dosage forms, coating processes, and hard and soft shell capsules • parenteral products

Modern Pharmaceutics Two Volume Set

Modern Pharmaceutics  Two Volume Set
Author: Alexander T. Florence,Juergen Siepmann
Publsiher: CRC Press
Total Pages: 1216
Release: 2016-04-19
ISBN: 1420065718
Category: Medical
Language: EN, FR, DE, ES & NL

Modern Pharmaceutics Two Volume Set Book Excerpt:

This new edition brings you up-to-date on the role of pharmaceutics and its future paradigms in the design of medicines. Contributions from over 30 international thought leaders cover the core disciplines of pharmaceutics and the impact of biotechnology, gene therapy, and cell therapy on current findings. Modern Pharmaceutics helps you stay current