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Drug Regulatory Affairs
Regulatory Affair and its Importance - Drug Discover and Development - Regulatory Strategy - Investigational New Drug Application IND - New Drug Application NDA - Abbreviated New Drug Application ANDA - Drug Master File DMF - Orphan Drug - Biological Licensing Application BLA - Registrationa of Drug Products in Overseas Markets Pharmaceutical export - Regulatory Authorities and Agencies - Overview of Drug and Cosmetic Act - Regulatory Guidelines - Useful Information
Forensic Pharmacy
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The Pharmaceutical Regulatory Process
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, an
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
Pharmaceutical Chemistry (English Edition)
Thakur publication Pvt. Ltd. Presenting "Pharmaceutical Chemistry" in English Edition book for d.pharm- 1st year as per PCI. The Pharmaceutical Chemistry book by Thakur Publication Pvt. Ltd. is a comprehensive guide for first-year students pursuing Diploma in Pharmacy (D.Pharm) as per the guidelines laid down by the Pharmacy Council of India (PCI). The book covers a wide range of topics related to the chemical and physical properties of drugs, drug interactions, and the synthesis and analysis of pharmaceutical compounds. It also includes detailed information on the principles of medicinal chemistry, drug design, and drug metabolism. With clear and concise explanations and numerous illustrations, this book is an essential resource for students to gain a thorough understanding of pharmaceutical chemistry and its applications in the pharmaceutical industry. This dual-color book evokes a sense of satisfaction and fosters a profound grasp of its content among students.
Pharmaceutics - I
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