This book deals with the ethical issues involved in bioequivalence study as per DCGI (Drug Controller General of India, New Delhi) as well as FDA guidelines. The concept of bioavailability and its study methodology in human volunteers have been discussed in detail with a special emphasis on protocol preparation, volunteer screening, informed consent, inclusion and exclusion criteria and study of pathological parameters prior to undertaking any bioequivalence study. Various methods of sample preparation and extraction of drug from plasma have been illustrated by different methods. The sophisticated techniques of solid phase extraction (SPE) system have been proved to be most simple, sensitive and time-saving. The different dimensions of its application and procedures have been highlighted. The procedures for evaluation of pharmacokinetic parameters and their interpretation have been illustrated with methodical approach. The application of microdialysis in bioavailability study as well as ocular kinetics and drug delivery system of ophthalmic medicines have also been discussed in this book.
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Textbook of Community Health Nursing