This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad

New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia

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

Industrial Pharmacy is the science of manufacturing, development, marketing and distribution of drug products, including quality assurance of the developed drug formulation. This book covers all topics required by students of Pharmacy. Industrial Pharmacy: A textbook is divided into two parts, ‘Industrial Pharmacy’ Part-I explains the formulation, manufacture, and quality control of tablets, capsules, parenteral dosage forms, liquid orals, ophthalmic dosage form and aerosols. In addition, topics such as ‘Pre-formulation’, ‘Cosmetics’ and ‘Packaging Material Science’ have also been briefly discussed. Part-II has been designed with the objective of imparting knowledge of the pilot plant scaleup considerations of different dosage forms. The students will be able to understand the technology transfer process from R&D to production with the necessary documentation. This book also provides information about drug regulations, roles and responsibilities of drug regulatory requirements such as ANDA and NDA, QMS.

Introducing the book "Industrial Pharmacy-II" is something that fills me with an incredible amount of joy. The content of this book has been meticulously crafted to adhere to the curriculum for Bachelor of Pharmacy students that has been outlined by the Pharmacy Council of India. An effort has been made to investigate the topic using terminology that is as straightforward as possible in order to make it more simply digestible for pupils. The book has a number of illustrations, such as flowcharts and diagrams that make it simple for students to comprehend complex ideas. It is the author's honest desire that both students and academicians would take something helpful away from reading this book.

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

"Textbook of Biochemistry BP 203T" is likely a textbook aimed at students pursuing a Bachelor of Pharmacy (B.Pharm) degree in India. It is written in clear and understandable language for students, and it covers the theoretical aspects of biochemistry, likely aligned with the Pharmacy Council of India (PCI) curriculum. The book is Primarily for B.Pharm students but may also be useful for students in other paramedical courses like B.Sc Nursing or D.Pharm where biochemistry is a core subject. The book is designed to be easy to understand and may include helpful features like, Clear and concise language & Diagrams and tables to illustrate concepts. It also includes all the basics of biochemistry including Introduction to biochemistry and its role in pharmacy, Cell structure and biochemical organizationBiomolecules like carbohydrates, proteins, lipids, and nucleic acids, Enzyme structure, function, and regulation, Metabolism of carbohydrates, proteins, and fats & Genetic material and its function.

The laws and regulations governing the pharmaceutical industry were adopted to protect the consuming public by attempting to provide drugs of constituent quality, purity, and efficacy. The Food, Drug and Cosmetic Act (the Act) is a living document in that it is amended frequently and interpreted constantly. The act may be imperfect, but careful attention to its provisions plus an effort of good faith by all persons concerned with drug manufacturing can produce the type of product for which the Act and its regulations strives. Even though the applicable laws and regulations may change with regard to specifics, there are, nonetheless, many constant applicable generally. This book serves an overview of the more significant laws, regulations and Acts. This text book describes the Food, Drug and Cosmetic Act, treats briefly regulations bearing on pharmaceutical manufacturing, looks at the structure, powers, and duties of the Food and Drug administration (FDA), describes state and local laws and regulations, and finally, covers the protection of industrial property and product liability.

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

It is with great pleasure that we introduce the book “Pharmaceutics-I”. The book allows for the lucid understanding of different dosage forms and processing methods. This book is a genuine effort to clarify the basics of Pharmaceutics in an effortless and interesting manner, as per the syllabus prescribed for the D.Pharm, Part I students by Board of Technical Education. All efforts have been made to keep the text error-free and to present the subject in a student friendly and easy to understand. However, any suggestions and constructive comments would be highly appreciated and incorporated in the future edition.