A entire creation for scientists engaged in new drug improvement, research, and approvals
Each yr the pharmaceutical around the world recruits millions of modern technology graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. even though, as a result of their restricted heritage in pharmaceutical research such a lot 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 heritage, make that transition, Pharmaceutical research for Small Molecules is a concise, but accomplished creation to the drug improvement procedure and research of chemically synthesized, small molecule medicines. It positive factors contributions by way of distinctive 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 ebook offers an creation to pharmaceutical research for small molecules (non-biologics) utilizing generic concepts for drug characterization and function checks. the motive force for to accomplish pharmaceutical analyses is submission of such info and helping files to regulatory our bodies for drug approval which will industry their items. furthermore, similar required helping reviews together with strong laboratory/documentation practices together with analytical tool qualification are highlighted during this book.
Topics coated include:
- Drug Approval procedure and Regulatory requisites (private standards)
- Pharmacopeias and Compendial Approval Process (public standards)
- Common equipment in pharmaceutical research (typically compendial)
- Common Calculations for assays and impurities and different particular tests
- Analytical strategy Validation, Verification, Transfer
- Specifications together with tips on how 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 device 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 worthy 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 insurance pros. It is also a great text/reference for graduate scholars in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.