Download e-book for kindle: Pharmaceutical Analysis for Small Molecules by Behnam Davani

A entire creation for scientists engaged in new drug improvement, research, and approvals 

Each 12 months the pharmaceutical all over the world recruits hundreds of thousands of modern technological know-how graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. although, due to their constrained heritage in pharmaceutical research so much of these new recruits locate making the transition from academia to very tough. Designed to help either contemporary graduates, in addition to skilled chemists or scientists with restricted regulatory, compendial or pharmaceutical research history, make that transition, Pharmaceutical research for Small Molecules is a concise, but entire creation to the drug improvement procedure and research of chemically synthesized, small molecule medicinal drugs. It beneficial properties contributions through uncommon specialists within the box, together with editor and writer, Dr. Behnam Davani, an analytical chemist with many years of technical administration and educating event in compendial, regulatory, and industry.

This e-book presents an creation to pharmaceutical research for small molecules (non-biologics) utilizing standard concepts for drug characterization and function exams. the driver for to accomplish pharmaceutical analyses is submission of such information and helping files to regulatory our bodies for drug approval for you to industry their items. additionally, comparable required aiding reports together with stable laboratory/documentation practices together with analytical software qualification are highlighted during this book.

Topics lined include:

• Drug Approval method and Regulatory specifications (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 approach 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 software skills together with IQ, OQ, PQ and VQ

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

Pharmaceutical research for Small Molecules is a necessary operating source for scientists at once or in a roundabout way concerned with the drug improvement approach, together with analytical chemists, pharmaceutical scientists, pharmacists, and caliber control/quality insurance pros. It is also a great text/reference for graduate scholars in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.