Novel Drug Delivery Systems | Transdermal Drug Delivery Systems | Mucoadhesive Drug Delivery Systems | Targeted Drugdelivery Systems | Regulatory Agencies | Quality Assurance | Good Manufacturing Practices | Validation

Targeted towards undergraduate and postgraduate students, the purpose of this textbook is to introduce pharmacy students to the basic systems of pharmaceutical principles and technologies applied in the preparation of various novel drug delivery systems. It also provides an in-depth introduction to the regulatory agencies and Current Good Manufacturing Practices (CGMP). This book caters to anyone who is interested in the subject or working in the industry, clinicians and research scholars. It is written in simple, lucid style with easily-understandable language so that it is useful for self study. The illustrations and tables provide a clear understanding of the concepts.

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.

Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Delivery of Drugs: Expectations and Realities of Multifunctional Drug Delivery Systems, Volume Two examines the formulation of micro-nanosized drug delivery systems and recaps opportunities for using physical methods to improve efficacy via mechano-, electroporation. The book highlights innovative delivery methods like PIPAC, including discussions on the regulatory aspects of complex injectables. Written by a diverse range of international researchers from industry and academia, the chapters examine specific aspects of characterization and manufacturing for pharmaceutical applications as well as regulatory and policy aspects. This book connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stakeholders. This level of discussion makes it a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about the status of drug delivery systems. Delivery of Drugs examines the fabrication, optimization, scale-up, biological aspects, regulatory and clinical success of various micro and nano drug delivery systems. The volume covers site and organ specific targeting approaches, technologies used in preparation of micro - nanoparticles, challenges of complex type of drug delivery forms and role of physical methods in achieving targeted drug effect. Written by a diverse range of international researchers the chapters examine the specific aspects of characterization and manufacturing of drug delivery system for pharmaceutical application and its regulatory aspects. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems.

March 18-20, 2019 Edinburgh, Scotland Bio-Pharmaceutics,Pharmaceutical Chemistry,Drug Targeting and Design,Pharmacokinetics and Pharmacodynamics in Drugs,Pharmaceutical Formulation,Pharmaceutical Manufacturing,Pharmaceutical Nanotechnology,Novel Drug Delivery Systems,Smart Drug Delivery Systems,Nanomedicine and Biomedical Applications,Biomaterials in Drug Delivery,Vaccine Drug Delivery Systems,Medical Devices for Drug Delivery,Biologics & Biosimilars,Pharmaceutical Analysis,Pharmaceutical Process Validation,Pharmaceutical Packaging,Clinical Trials and Clinical Research,Pharmacogenetics and Genomics,Regulatory Affairs and Intellectual Property Rights,Industrial and Physical Pharmacy,Clinical and Hospital Pharmacy,Pharmacovigilance and Drug Safety,Pharmacy Education and Practice,