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Sample Preparation of Pharmaceutical Dosage Forms
This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.
Two Tankers Down
A riveting account of the greatest small-boat rescue in American history.
Natural Born Fluxus - Childhood Event Scores by Fluxus Artists
Natural Born Fluxus is that tendency among artists to engage in Fluxus-like behaviors even if they never heard of Fluxus. Or possibly we could say that Fluxus ideas come out of a naturally occurring tendency in all artists that we now think of as Fluxus. It could be that the free wheeling nature of Fluxus allows artists to enjoy their creative, or at least peculiar, tendencies in an unfettered way that other forms of organized artistic activities do not. Includes: Peter Frank, Cecil Touchon, John M. Bennett, Ruud Janssen, Don Boyd, Keith Buchholz, Adam Overton, Sheila E. Murphy, Madawg, Litsa Spathi, Gregory Steel, Mark Block, Christine Tarantino, Allan Revich, Lorraine Kwan, Matthew Rose, Reid Wood, Luc Fierens, Brad Brace, Mary Campbell, Zachary Scott Lawrence, Bibiana Padilla Maltos, Eric KM Clark, Brian R. Nickerson, Walter Cianciusi, Neil Horsky, Roger Stevens, Matt Taggart, Anya E.V. Liftig, Yves Maraux, Roland Halbritter.
Formulation and Analytical Development for Low-Dose Oral Drug Products
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Poorly Soluble Drugs
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the moder...
