By Behnam Davani
A accomplished advent for scientists engaged in new drug improvement, research, and approvals
Each yr the pharmaceutical around the globe recruits hundreds of thousands of contemporary technological know-how graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. even though, due to their constrained historical past 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 advent to the drug improvement procedure and research of chemically synthesized, small molecule medicines. It gains contributions via extraordinary 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 publication offers an creation to pharmaceutical research for small molecules (non-biologics) utilizing prevalent suggestions for drug characterization and function assessments. the motive force for to accomplish pharmaceutical analyses is submission of such info and aiding files to regulatory our bodies for drug approval for you to marketplace their items. additionally, comparable required aiding reviews together with strong laboratory/documentation practices together with analytical software qualification are highlighted during this book.
Topics coated include:
- Drug Approval method and Regulatory necessities (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 strategy Validation, Verification, Transfer
- Specifications together with the way to deal with out of specification (OOS) and out of development (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 issues on either regulatory (ICH) and Compendial harmonization also are highlighted.
Pharmaceutical research for Small Molecules is a helpful operating source for scientists without delay or in a roundabout way concerned with the drug improvement strategy, together with analytical chemists, pharmaceutical scientists, pharmacists, and caliber control/quality coverage execs. It is also an outstanding text/reference for graduate scholars in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
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