Rick Ng's Drugs: From Discovery to Approval PDF

By Rick Ng

ISBN-10: 047019510X

ISBN-13: 9780470195109

A finished consultant to the complicated and long procedure wherein a drug arrives out there. the method has parts of medical learn, clinical ethics, company, and rules; information convey that out of 5,000 compounds with preliminary promise, 5 will move into human scientific trials and one becomes an licensed drug. The reference lists present FDA and eu directions and covers regulatory professionals and strategies in Japan and China. Of curiosity to pros within the pharmaceutical in addition to scholars of pharmacy, drugs, or lifestyles sciences and others attracted to drug discovery. Ng is supervisor of regulatory affairs for the Biopharmaceutical production expertise Centre, Singapore"

Show description

Read Online or Download Drugs: From Discovery to Approval PDF

Best pharmacy books

New PDF release: Bioadhesive drug delivery systems: fundamentals, novel

This important reference offers a finished overview of the elemental equipment for characterizing bioadhesive fabrics and bettering motor vehicle focusing on and uptake-offering probabilities for reformulating latest compounds to create new prescription drugs at reduce improvement expenditures. Evaluates the original provider features of bioadhesive polymers and their energy to reinforce localization of introduced brokers, neighborhood bioavailability, and drug absorption and delivery!

Download e-book for kindle: Cytochrome P450: Structure, Mechanism, and Biochemistry by Paul R. Ortiz de Montellano

This authoritative Fourth variation summarizes the advances of the previous decade in regards to the constitution, mechanism, and biochemistry of cytochrome P450 enzymes, with adequate assurance of past paintings to make each one bankruptcy a accomplished assessment of the sector. 13 chapters are divided into particular volumes, the 1st overlaying the basics of cytochrome P450 biochemistry, in addition to the microbial, plant, and bug structures, and the second one completely targeting mammalian platforms.

Design and Manufacture of Pharmaceutical Tablets - download pdf or read online

Layout and Manufacture of Pharmaceutical pills deals genuine international suggestions and results of formula and processing demanding situations of pharmaceutical capsules. This ebook comprises various functional examples regarding genuine formulations which have been tested and advertised and covers vital information within the parts of balance, dissolution, bioavailibity and processing.

Oxford Handbook of Clinical Pharmacy - download pdf or read online

Now totally up to date for a moment version, the Oxford instruction manual of scientific Pharmacy continues to be the indispensible advisor to scientific pharmacy, supplying the entire details wanted for working towards and scholar pharmacists. offering convenient useful information in a quick-reference, bullet-point layout, it is going to offer the information and self assurance you must supply a scientific pharmacy provider.

Additional resources for Drugs: From Discovery to Approval

Sample text

The conventional method for drug discovery is the irrational approach. It involves scanning thousands of potential compounds from natural sources for a hit against specific assays that represent the target (more about this in Chapter 3). This procedure has been likened to finding a needle in a haystack. In our analogy, it is like trying out many keys to find a fit to a lock. As we can imagine, such a process is somewhat random and cumbersome. The chances of failure are high, although it should be kept in mind that many drugs on the market today were discovered in this manner.

Each EST of interest can be compared with sequences in proteins, and the degree of match can be determined. A technique called threading is used. This involves using data on three-dimensional (3D) protein structure, coupled with knowledge of the physicochemical properties of amino acids, to determine if the amino acid sequence is likely to fold in the same way as a sequence for which the structure is known. In this way, more information about the putative target protein can be assessed. 4 TARGET VALIDATION Once a potential disease-causing target has been identified, a process of validation is carried out to confirm the functions and effects of the target.

8 REVIEW QUESTIONS 1. Provide a definition for the term “drug” as adopted in this book. 2. Describe the process from drug discovery to approval. 3. Describe the role of regulatory bodies such as the FDA and EMEA. What are their main concerns about drugs? 4. Explain the terms GLP, GCP, and GMP. Why are these necessary? 5. Discuss how Lipitor and Nexium work in the body. 6. Explain the reason for the high R&D cost for drugs, and discuss how the cost can be reduced. 7. Explain why intellectual properties are important to pharmaceutical companies and how they can be protected.

Download PDF sample

Drugs: From Discovery to Approval by Rick Ng


by Charles
4.2

Rated 4.54 of 5 – based on 29 votes