Welcome to our book review site go-pdf.online!
You may have to Search all our reviewed books and magazines, click the sign up button below to create a free account.
Generic Drug Product Development
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 dru
Generic Drug Product Development
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 therapeutica
Bioequivalence Requirements in Various Global Jurisdictions
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Juri...
Advanced Aseptic Processing Technology
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies
Good Design Practices for GMP Pharmaceutical Facilities
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Encyclopedia of Pharmaceutical Technology
The Encyclopedia of Pharmaceutical Technology presents authoritative and contemporary articles on all aspects of drug development, dosage forms, manufacturing, and regulation-enabling the specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and a solid investment for years to come--maintaining currency through its supplements [Volume 18/Supplement 1: Published November, 1998] The Encyclopedia contains interdisciplinary contributions in a wide array of subjects, including Drugs decomposition metabolism pharmaceutical incompatibilities pharmacokinetics physicochemical properties preformulation stability Drug Delivery Systems and Devices-Development and Manufacture analysis and controls bioavailability use of computerization formulation and processing alternatives national and international registration packaging patents process validation scale-up safety and efficacy stability standards Post-Production and Practical Considerations governmental/industrial/professional organizations legal aspects national and international agencies patent life of drugs patient compliance ...and much, much more!
Dermal Absorption and Toxicity Assessment
The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six well organized sections. Written by internationally recognized experts in the field, this Second Edition is a complete revised and updated text, covering the wide range of methods used to assess skin ab
Paving the Path to Discoveries and Unlocking the Secrets of N-Heterocycles
This book is a groundbreaking exploration of N-heterocycles, encompassing their historical significance, current prospects, and diverse biological applications. The book's primary objectives are to unravel the historical evolution of N-heterocycles, elucidate their contemporary relevance, and investigate their crucial role in various scientific domains. This book fills a substantial knowledge gap by offering a holistic perspective on N-heterocycles, fostering a profound understanding of their diverse applications, inspiring future research directions, and serving as a vital educational resource. It employs a multifaceted approach, including historical analysis, literature review, case studie...
Alkaloids
The book Alkaloids - Alternatives in Synthesis, Modification, and Application collects several chapters written by distinguished scientists and recognized experts in their respective fields of research. The purpose of this book is to focus the attention of a broad range of students, researchers, and specialists on some innovative and highly perspective areas in alkaloid research. The book covers several topics, guiding the readers from the development of nonconventional biotechnologies for alternative production of valuable alkaloids, through the application of modern chemical methods of asymmetric synthesis for production of synthetic and semisynthetic alkaloid derivatives, medicinal application of alkaloids as anesthetics and pain-relief drugs, analytical techniques for alkaloid profiling and their application in chemotaxonomy, quality control and standardization of raw plant material, to the importance of the control and reduction of alkaloid contents during production of animal feedstuffs.
Topical Drug Bioavailability, Bioequivalence, and Penetration
This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.
