Oral Formulation Roadmap From Early Drug Discovery To Development

Author : Elizabeth Kwong
Publisher : John Wiley & Sons
ISBN 13 : 1118907906
Total Pages : 272 pages
Book Rating : 4.00/5 ( download)

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Download or read book Oral Formulation Roadmap from Early Drug Discovery to Development written by Elizabeth Kwong and published by John Wiley & Sons. This book was released on 2017-01-03 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

Author : Daniel Bar-Shalom
Publisher : Springer Science & Business Media
ISBN 13 : 1489980113
Total Pages : 429 pages
Book Rating : 4.13/5 ( download)

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Download or read book Pediatric Formulations written by Daniel Bar-Shalom and published by Springer Science & Business Media. This book was released on 2014-01-30 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

Author : Mitchell N. Cayen
Publisher : John Wiley & Sons
ISBN 13 : 1118035208
Total Pages : 507 pages
Book Rating : 4.07/5 ( download)

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Download or read book Early Drug Development written by Mitchell N. Cayen and published by John Wiley & Sons. This book was released on 2011-02-25 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Author : Ahmed F. Abdel-Magid
Publisher : John Wiley & Sons
ISBN 13 : 0470043393
Total Pages : 341 pages
Book Rating : 4.94/5 ( download)

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Download or read book Fundamentals of Early Clinical Drug Development written by Ahmed F. Abdel-Magid and published by John Wiley & Sons. This book was released on 2006-09-29 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: An informative look at the intricacies of today's drug development process Once a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield. This book covers both recent advances in the design and synthesis of new drugs, as well as the myriad other issues facing a new drug candidate as it moves through the development process. Utilizing recent case studies, the authors provide valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation. Both novice and active researchers will appreciate the inclusion of chapters on such diverse topics as: * Cross-coupling methods * Asymmetric synthesis * Automation * Chemical Engineering * Application of radioisotopes * Final form selection * Formulations * Intellectual property A wealth of real-world examples and contributions from leading process scientists, engineers, and related professionals make this book a valuable addition to the scientific literature.

Author : A. Wallace Hayes
Publisher : CRC Press
ISBN 13 : 1000875776
Total Pages : 2143 pages
Book Rating : 4.75/5 ( download)

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Download or read book Hayes' Principles and Methods of Toxicology written by A. Wallace Hayes and published by CRC Press. This book was released on 2023-07-03 with total page 2143 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.

Author : Chao Han
Publisher : John Wiley & Sons
ISBN 13 : 0470574887
Total Pages : 303 pages
Book Rating : 4.81/5 ( download)

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Download or read book Evaluation of Drug Candidates for Preclinical Development written by Chao Han and published by John Wiley & Sons. This book was released on 2010-01-06 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the "right" drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.

Author : Veland Ramadani
Publisher : Springer Nature
ISBN 13 : 9819951186
Total Pages : 376 pages
Book Rating : 4.85/5 ( download)

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Download or read book Research on Islamic Business Concepts written by Veland Ramadani and published by Springer Nature. This book was released on 2023-11-16 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: This proceedings volume presents selected chapters from the 13th Global Islamic Marketing Conference, featuring contributions from renowned experts from around the world. The chapters offer an up-to-date overview of research and insights into Islamic business practices, with a specific focus on Islamic marketing and entrepreneurship strategies. Authored by experts hailing from diverse countries such as Malaysia, Indonesia, India, Pakistan, United Arab Emirates, Jordan, and Morocco, the chapters collectively provide a comprehensive understanding of the subject matter. Covering a wide range of topics including understanding Muslim consumer behavior and marketing, halal tourism and healthcare, entrepreneurship and business in Muslim societies, women empowerment and entrepreneurship, Islamic ethics and values in organizations, psychological factors and social issues, technology and future trends, and social and labor issues in Muslim societies, this book encompasses a global perspective on the subject matter. With the expertise and diverse backgrounds of the contributing authors, this book serves as an invaluable resource for researchers interested in delving into the intricacies of Islamic business practices. It also offers valuable insights and practical implications for business consultants seeking a deep understanding of conducting business in Islam-oriented regions. The collective knowledge and experiences shared by these renowned experts contribute to a comprehensive exploration of the topic, making this volume a significant contribution to the field of Islamic marketing and business studies.

Author : Fabrizio Giordanetto
Publisher : John Wiley & Sons
ISBN 13 : 3527801766
Total Pages : 816 pages
Book Rating : 4.63/5 ( download)

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Download or read book Early Drug Development written by Fabrizio Giordanetto and published by John Wiley & Sons. This book was released on 2018-06-11 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
ISBN 13 : 3527812202
Total Pages : 352 pages
Book Rating : 4.02/5 ( download)

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Download or read book Innovative Dosage Forms written by Yogeshwar Bachhav and published by John Wiley & Sons. This book was released on 2019-08-09 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Author : Saravanan, Muthupandian
Publisher : IGI Global
ISBN 13 : 1799850501
Total Pages : 559 pages
Book Rating : 4.02/5 ( download)

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Download or read book Handbook of Research on Nano-Strategies for Combatting Antimicrobial Resistance and Cancer written by Saravanan, Muthupandian and published by IGI Global. This book was released on 2021-02-12 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multidrug-resistant bacteria play a significant role in public health by destroying the potency of existing antibiotics. Meanwhile, cancer remains one of the most common health problems that impact society, resulting in many deaths worldwide. Novel strategies are required to combat antimicrobial resistance and create efficient anticancer drugs that could revolutionize treatment. Nanomedicine is one such innovation that plays a significant role in developing alternative and more effective treatment strategies for antimicrobial resistance and cancer theranostics. The Handbook of Research on Nano-Strategies for Combatting Antimicrobial Resistance and Cancer is an essential scholarly resource that examines (1) how to overcome the existing, traditional approaches to combat antimicrobial resistance and cancer; (2) how to apply multiple mechanisms to target the cancer cells and microbes; and (3) how the nanomaterials can be used as carriers. Featuring a range of topics such as bacteriophage, nanomedicine, and oncology, this book is ideal for molecular biologists, microbiologists, nanotechnologists, academicians, chemists, pharmacists, oncologists, researchers, healthcare professionals, and students.