Biopharmaceuticals : biochemistry and biotechnology / Gary Walsh.

pharmacy bookfair2016

Includes bibliographical references and index.

Contents -- Preface -- Chapter 1 Pharmaceuticals, biologics and biopharmaceuticals -- Introduction to pharmaceutical products -- Biopharmaceuticals and pharmaceutical biotechnology -- History of the pharmaceutical industry -- The age of biopharmaceuticals -- Biopharmaceuticals: current status and future prospects -- Traditional pharmaceuticals of biological origin -- Pharmaceuticals of animal origin -- The sex hormones -- The androgens -- Oestrogens -- Progesterone and progestogens -- Corticosteroids -- Catecholamines -- Prostaglandins Pharmaceutical substances of plant origin Alkaloids -- Atropine and scopalamine -- Morphine and cocaine -- Additional plant alkaloids -- Ergot alkaloids -- Flavonoids, xanthines and terpenoids -- Cardiac glycosides and coumarins -- Aspirin -- Pharmaceutical substances of microbial origin -- The macrolides and ansamycins -- Peptide and other antibiotics -- Conclusion -- Further reading -- Chapter 2 The drug development process -- Drug discovery -- The impact of genomics and related technologies upon drug discovery -- Gene chips -- Proteomics -- Structural genomics -- Pharmacogenetics -- Plants as a source of drugs -- Microbial drugs Rational drug design Combinatorial approaches to drug discovery -- Initial product characterization -- Patenting -- What is a patent and what is patentable? -- Patent types -- The patent application -- Patenting in biotechnology -- Delivery of biopharmaceuticals -- Oral delivery systems -- Pulmonary delivery -- Nasal, transmucosal and transdermal delivery systems -- Pre-clinical trials -- Pharmacokinetics and pharmacodynamics -- Toxicity studies -- Reproductive toxicity and teratogenicity -- Mutagenicity, carcinogenicity and other tests -- Clinical trials -- Clinical trial design -- Trial size and study population Randomized control studies Additional trial designs -- The role and remit of regulatory authorities -- The Food and Drug Administration -- The investigational new drug application -- The new drug application -- European regulations -- National regulatory authorities -- The EMEA and the new EU drug approval systems -- The centralized procedure -- Mutual recognition -- Drug registration in Japan -- World harmonization of drug approvals -- Conclusion -- Further reading -- Chapter 3 The drug manufacturing process -- International pharmacopoeia -- Martindale, the Extra Pharmacopoeia -- Guides to good manufacturing practice The manufacturing facilityClean rooms -- Cleaning, decontamination and sanitation (CDS) -- CDS of the general manufacturing area -- CDS of process equipment -- Water for biopharmaceutical processing -- Generation of purified water and water for injections (WFI) -- Distribution system for WFI -- Documentation -- Specifications -- Manufacturing formulae, processing and packaging instructions -- Records -- Generation of manufacturing records -- Sources of biopharmaceuticals -- E. coli as a source of recombinant, therapeutic proteins -- Expression of recombinant proteins in animal cell culture systems