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Steps to Implementing Pharmacogenomics (PGx) in Your Practice
DEFINITIONS, NOMENCLATURE, AND DESIGNATIONS
| Allele | Alternate sequences or versions of the same gene inherited from each parent. |
| Gene | Regions of the DNA that contain the instructions to make proteins. |
| Genome | The entire DNA of an organism. |
| Genotype | The specific set of alleles inherited at a locus on a given gene. |
| Mutation | A change in DNA sequence between individuals. |
| Pharmacogenetics | The study of a gene involved in response to a drug. |
| Pharmacogenomics | The study of many genes, in some cases the entire genome, involved in responses to drugs. |
| Polymorphism | A mutation in DNA in a given population that may be observed at greater than 1% frequency. |
| Single Nucleotide Polymorphism (SNP) | A variant DNA sequence in which a single nucleotide has been replaced by another base. |
NOMENCLATURE FOR CYTOCHROME P450 ENZYMES
In this system, the CYP is the "superfamily" followed by a number for the "family," letter for the "subfamily," number for an "individual member" followed by an "*" asterisk designating an allele defined by integers, letters, etc. The "*" is pronounced "star," so the above allele would be the *2A allele/suballele.
In this convention, the *1 allele is most commonly referred to as the "wild-type" gene, or the "normal" or "common" gene, whereas integers of "2" or greater denote polymorphic alleles typically numbered in order of their discovery and validation (i.e., *2).
Next week, we will look at the roles of the different "alleles" in ADME and receptor affinity for the drug.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
Indian Active Pharmaceutical Ingredient Maker Scolded for Not Ensuring River Water It Uses is Safe
The FDA warned an Indian active pharmaceutical ingredient (API) maker that it had not ensured the water it gets from a nearby river is sanitary before using it to make its products. In the warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 despite the fact that the water passes through farmland where it is subject to agricultural runoff and animal waste, and is stored in a tank with a hole in it that does not protect it from dirt and debris.
http://www.fiercepharma.com/manufacturing/fda-scolds-indian-api-maker-for-not-ensuring-river-water-it-uses-safe
Second Banned Manufacturer Still Shipping Active Pharmaceutical Ingredients
China's Lumis Global Pharmaceuticals has been sent a warning letter for selling active pharmaceutical ingredients (APIs) it got from a supplier on the FDA import alert list, then faking Certificates of Analysis (COA). When the FDA has serious concerns about the APIs or drugs made at a facility outside the U.S., it often will place it on its import alert list to prevent the products from entering the U.S. However, that is not a guarantee they won't get in.
This is the second time in recent months that the FDA has slapped a Chinese company with a warning letter after finding that it was buying products from a banned supplier, faking COA and then shipping the APIs as their own.
http://www.fiercepharma.com/manufacturing/second-chinese-company-found-shipping-apis-from-banned-manufacturer
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