Product Description: Over-the-Counter products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separately because of their development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products...read more

This pocket guide provides a step-by-step approach to the mathematics and knowledge needed for the accurate calculation of drug doses. This edition contains expanded coverage of intravenous medication and insulin administration. Also included are end-of-chapter practice problems and new chapters covering paediatric and geriatric dose calculation. Other features new to this edition include a pre-assessment test; an expanded chapter on intravenous drug therapies; a new appendix identifying components of a drug label; and an inside-cover display of frequently-used formulas.

Product Description: The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process...read more

An authoritative and practical guide to the art and science of formulating drugs. With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development. Divided conveniently into two parts―regulatory and manufacturing guidelines, and formulations―each volume in the set covers: cGMP compliance pre-approval inspections stability and bioequivalence testing packaging commodity development common difficulties in formulating drugs changes to aNDAs

Product Description: Pharmaceutical formulations remain as much an art today as they have evolved into complex science. With exponential growth of generic formulations, the need for ready formulations has increased. Essentially an authoritative and practical guide to the art and science of formulating drugs, the six-volume handbook contains the Bill of Materials and Manufacturing Directions for over 2000 drug formulations, including a number of biotechnology and patented drugs...read more

The second volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution and other similar products from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing uncompressed drugs and the common elements of formulations.

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs and the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.

Product Description: The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations...read more