{"product_id":"pharmaceutical-analysis-for-small-molecules","title":"Pharmaceutical Analysis for Small Molecules","description":"\u003cp\u003e\u003cb\u003eA comprehensive introduction for scientists engaged in new drug development, analysis, and approvals\u003c\/b\u003e \u003c\/p\u003e \u003cp\u003eEach year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, \u003ci\u003ePharmaceutical Analysis for Small Molecules\u003c\/i\u003e is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry.\u003c\/p\u003e \u003cp\u003eThis book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory\/documentation practices including analytical instrument qualification are highlighted in this book.\u003c\/p\u003e \u003cp\u003eTopics covered include:\u003c\/p\u003e \u003cul\u003e\n\u003cli\u003eDrug Approval Process and Regulatory Requirements (private standards)\u003c\/li\u003e\n\u003cli\u003ePharmacopeias and Compendial Approval Process (public standards)\u003c\/li\u003e\n\u003cli\u003eCommon methods in pharmaceutical analysis (typically compendial)\u003c\/li\u003e\n\u003cli\u003eCommon Calculations for assays and impurities and other specific tests\u003c\/li\u003e\n\u003cli\u003eAnalytical Method Validation, Verification, Transfer\u003c\/li\u003e\n\u003cli\u003eSpecifications including how to handle out of specification (OOS) and out of trend (OOT)\u003c\/li\u003e\n\u003cli\u003eImpurities including organic, inorganic, residual solvents and elemental impurities\u003c\/li\u003e\n\u003cli\u003eGood Documentation Practices for regulatory environment\u003c\/li\u003e\n\u003cli\u003eManagement of Analytical Laboratories\u003c\/li\u003e\n\u003cli\u003eAnalytical Instrument Qualifications including IQ, OQ, PQ and VQ\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eDue to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted.\u003c\/p\u003e \u003cp\u003e\u003ci\u003ePharmaceutical Analysis for Small\u003c\/i\u003e \u003ci\u003eMolecules\u003c\/i\u003e is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control\/quality assurance professionals. It also is an excellent text\/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":32098908962899,"sku":"","price":116.99,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0278\/1295\/4195\/files\/9781119121114.jpg?v=1780378271","url":"https:\/\/agendabookshop.com\/products\/pharmaceutical-analysis-for-small-molecules","provider":"Agenda Bookshop","version":"1.0","type":"link"}