Writing & Executing a Software Validation Protocol: Plain and Simple, Year 2013
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results. While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims, experienced folks will likely find nuggets to help improve their efforts.
Deskbook of Pharmaceutical Dissolution Science and Applications , has been contributed and written by Expert Scientists across the Globe. The aim to provide the Academia, Industry and Research Scientists an overview of Basics and Fundamentals in the dissolution science and testing, recent developments in instrumentation and automation, changing regulatory requirements and innovations in the area of dissolution science and dissolution / in vitro release for novel dosage forms. The chapters provide details about the instrument operations, tip to overcome problems in desing and development with adequate literature citations. The chapters also reveal methods of statistical analysis and interpretation of dissolution test data; application of data in terms of correlation with bioavailability and bioequivalence. This is a unique book of its kind
Edited by Tim Sandle and Madhu Raju Saghee.
ISBN 978-0-9573491-6-2 (Hb) ISBN 978-0-9956666-0-3 (Pb)