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.

Nanocarriers for the Delivery of Combination Drugs focuses on the role of nanocarriers in the delivery of combination drugs for the management and treatment of various diseases. Nanocarriers belonging to the category of polymeric nanoparticles, dendrimers, lipidic nanocarriers (like nanoemulsions), liposomes, solid lipid nanoparticles, nanostructured lipid carriers are now being used in the drug delivery of combination drugs. This book helps readers assimilate all the information available surrounding the application of various nanocarrier technologies for the delivery of combination drugs of synthetic and natural origin, including small and large molecules. This is an important reference source for pharmaceutical scientists and biomaterials scientists who are looking to gain an increased understanding on how nanotechnology is improving the efficiency of combination drug delivery.