Novel Drug Delivery Systems And Regulatory Affairs

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.

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. 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. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

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.

Drug Regulatory Affairs is a compilation of fundamental concepts pertaining to pharmaceutical drug regulation. Governments protect public health by strictly controlling the safety and efficacy of human medicine, veterinary medicines, medical devices, cosmetics and complementary medicines. Companies responsible for the discovery, testing, manufacture and marketing of these products must ensure sale of safe and effective products. Drug Regulatory Affairs refers to fulfilment of all aspects of drug regulations within the pharmaceutical companies from development process to finished product marketing. The book provides a sound basis on understanding of international drug regulatory guidelines controlling the quality, safety and purity of marketed drugs. The content of this book covers the syllabus of pharmacy undergraduate and postgraduate course content of drug regulatory affairs. The text focuses on delivering updated and reviewed up-to-date information on current global regulatory guidelines. The book contains information that is substantial to a comprehensive understanding of regulatory affairs and the practice in pharmaceutical industry.