By Rick Ng
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"
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Additional resources for Drugs: From Discovery to Approval
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.
Drugs: From Discovery to Approval by Rick Ng