Drugs: From Discovery to Approval by Rick Ng

By Rick Ng

A complete consultant to the complicated and long strategy wherein a drug arrives out there. the method has parts of medical examine, scientific ethics, company, and rules; records exhibit that out of 5,000 compounds with preliminary promise, 5 will pass into human medical trials and one turns into an licensed drug. The reference lists present FDA and eu directions and covers regulatory professionals and approaches in Japan and China. Of curiosity to execs within the pharmaceutical in addition to scholars of pharmacy, medication, or lifestyles sciences and others drawn to drug discovery. Ng is supervisor of regulatory affairs for the Biopharmaceutical production know-how Centre, Singapore"

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1 Types of Interactions Binding between drug molecule and receptor or enzyme is critically dependent on the shapes and sizes of the molecules. To deliver therapeutic actions, drug molecules with the right shapes and sizes have to be designed to fit into the binding sites (pockets) of the receptor or enzyme. Another important factor is the nature of the coupling. Before a drug can fit into the binding site, it has to overcome thermal and vibrational motions at the cellular level. The attractive forces must be strong enough for the drug to dock with the binding site.

It is prescribed for the relief of pain and symptoms of osteoarthritis and rheumatoid arthritis. Previously, nonsteroidal anti-inflammatory drugs (NSAIDs) were used. NSAIDs inhibit both COX-1 and COX-2 enzymes and cause stomach bleeding (see Case Study #2). Lipase Inhibitor: Orlistat (Xenical, Roche) is prescribed for the treatment of obesity. It inhibits the gastrointestinal lipase enzymes by binding to the lipase through the serine site and inactivates the enzyme. Fat in the form of triglycerides cannot be hydrolyzed by the lipase and converted to free fatty acids and monoglycerides.

When the enzyme GTPase hydrolyzes GTP to GDP and removes the phosphate group, the trimeric subunits change back to the inactivated state. This receptor is once again ready to receive and transmit further signals. 3 Selected Drugs and Target Receptors Drug Amlodipine (Norvasc, Pfizer) Atorvastatin (Lipitor, Pfizer) Augmentin/amoxicillin plus clavulanic acid (GlaxoSmithKline) Bevacizumab (Avastin, Genentech) Celecoxib (Celebrex, Pharmacia) Clopidogrel (Plavix, BMS/Sanofi-Aventis) Erythropoietin (Epogen, Amgen) Erythropoietin (Procrit, Ortho Biotech) Esomeprazole (Nexium, AstraZeneca) Etanercept (Enbrel, Amgen) Fluoxetine (Prozac, Eli Lilly) Lansoprazole (Takepron, Takeda) Loratadine (Claritin, Schering) Olanzapine (Zyprexa, Eli Lilly) Omeprazole (Losec, AstraZeneca) Paroxetine (Seroxat, GlaxoSmithKline) Sertraline (Zoloft, Pfizer) Simvastatin (Zocor, Pfizer) Trastuzumab (Herceptin, Genentech) Venlafaxine (Effexor, Wyeth) a Therapeutic Category Drug Target Cardiovascular Cardiovascular Anti-infective Ion channel Enzyme inhibitor Enzyme inhibitor Cancer Musculoskeletal Vascular endothelial growth factor inhibitor Enzyme inhibitor Hematology Platelet receptor inhibitor Hematology Transmembrane agonist Hematology Transmembrane agonist Gastrointestinal/ metabolism Rheumatoid arthritis Central nervous system Gastrointestinal/ metabolism Respiratory Ion channel GPCR Central nervous system GPCR Gastrointestinal/ metabolism Central nervous system Ion channel Central nervous system Cardiovascular Cancer GPCR Enzyme inhibitor Overexpressed HER2 protein Serotonin-norepinephrine reuptake inhibitor Central nervous system TNF-α GPCRa Ion channel GPCR GPCR = G-protein coupled receptor.

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