A complete advent for scientists engaged in new drug improvement, research, and approvals 

Each yr the pharmaceutical around the globe recruits millions of modern technological know-how graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. in spite of the fact that, due to their constrained history in pharmaceutical research so much of these new recruits locate making the transition from academia to very tricky. Designed to help either fresh graduates, in addition to skilled chemists or scientists with restricted regulatory, compendial or pharmaceutical research heritage, make that transition, Pharmaceutical research for Small Molecules is a concise, but entire creation to the drug improvement technique and research of chemically synthesized, small molecule medicinal drugs. It gains contributions via exclusive specialists within the box, together with editor and writer, Dr. Behnam Davani, an analytical chemist with a long time of technical administration and educating event in compendial, regulatory, and industry.

This e-book offers an creation to pharmaceutical research for small molecules (non-biologics) utilizing well-known innovations for drug characterization and function checks. the motive force for to accomplish pharmaceutical analyses is submission of such information and helping files to regulatory our bodies for drug approval with a purpose to industry their items. moreover, similar required aiding reviews together with reliable laboratory/documentation practices together with analytical device qualification are highlighted during this book.

Topics lined include:

• Drug Approval approach and Regulatory standards (private standards)
• Pharmacopeias and Compendial Approval Process (public standards)
• Common tools in pharmaceutical research (typically compendial)
• Common Calculations for assays and impurities and different particular tests
• Analytical technique Validation, Verification, Transfer
• Specifications together with how you can deal with out of specification (OOS) and out of pattern (OOT)
• Impurities together with natural, inorganic, residual solvents and elemental impurities
• Good Documentation Practices for regulatory environment
• Management of Analytical Laboratories
• Analytical tool skills together with IQ, OQ, PQ and VQ

Due to worldwide nature of pharmaceutical undefined, different themes on either regulatory (ICH) and Compendial harmonization also are highlighted.

Pharmaceutical research for Small Molecules is a useful operating source for scientists without delay or in some way concerned with the drug improvement strategy, together with analytical chemists, pharmaceutical scientists, pharmacists, and caliber control/quality coverage pros. It is also an outstanding text/reference for graduate scholars in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.