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This blog is focused on discussing some of the terminology you may come across while dealing with Quality Control/Assurance or regulatory compliance in a Pharmaceutical/ Life sciences Industry environment.
We may not dedicate many blogs on this, but briefly going over them, will provide us the acquaintance with theses terms and may help understand them better whenever they are referenced in other documents/ blogs. These are as follows:
Pharmaceutics: discipline of pharmacology that involves evaluation, design and preparation of suitable dosage forms of chemical entities and delivery systems. This discipline is targeted towards optimizing drug action as well as minimizing adverse effects. Pharmaceutics involves studies from interdependent areas such as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology.
Pharmacokinetics: is the study of the time course of drug in different fluids, tissues, and excreta of the body (effect of body on the drug).
ADME (T): is a term used for absorption, distribution, metabolism, excretion and toxicology studies.
Pharmacodynamics: study of the physiological effects of ingested drugs within or on the body. (effect of drug on the body).
Pharmacogenomics: study of how an individual's genetic constitution affects body's response to drugs.
Pharmaceutical Formulation: process in which different substances, including the active drug, are combined to produce a final medicinal product.
Biologics: studying a wide range of medicinal products of biological origin. Examples are vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. In most of the jurisdictions worldwide, biologics are regulated in a different manner than are drugs and medical devices.
Bioequivalence: United States Food and Drug Administration (FDA) has defined bioequivalence as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. These studies are mainly conducted to compare two products such as a commercially-available Brand product and a potential to-be-marketed Generic product.
Bioavailability: is the fraction of the administered dose that reaches the systemic circulation.
Potency and Efficacy: Potency refers to the amount of drug (usually expressed in milligrams) needed to produce an effect. Efficacy refers to the potential maximum therapeutic response that a drug can produce.
Dose Response: measured as LD50 or statistically-derived dose that is lethal to 50% of a modeled population.
Pharmacovigilance: is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications.
References:
1. Gibaldi, M. and Perrier, D. 1975 Pharmacokinetics, Marcel Dekker, page v.
2. J. Lazarou, B. H. Pomeranz, and P. N. Corey. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. Apr 15, 1998. 279(15):1200-5.
3. J. Hodgson, and A. Marshall. Pharmacogenomics: will the regulators approve? Nature Biotechnolgy. 16: 243-246. 1998.
4. S. Pistoi. Facing your genetic destiny, part II. Scientific American. February 25, 2002.
5. Genomics.energy.gov
6. Wikipedia (en.wikipedia.org)
7. accelrys.com
8. http://www.fas.org/ota/reports/7401.pdf
9. http://aquaticpath.umd.edu/appliedtox/dose-response.pdf
10. www.fda.gov
This blog is focused on discussing some of the terminology you may come across while dealing with Quality Control/Assurance or regulatory compliance in a Pharmaceutical/ Life sciences Industry environment.
We may not dedicate many blogs on this, but briefly going over them, will provide us the acquaintance with theses terms and may help understand them better whenever they are referenced in other documents/ blogs. These are as follows:
Pharmaceutics: discipline of pharmacology that involves evaluation, design and preparation of suitable dosage forms of chemical entities and delivery systems. This discipline is targeted towards optimizing drug action as well as minimizing adverse effects. Pharmaceutics involves studies from interdependent areas such as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology.
Pharmacokinetics: is the study of the time course of drug in different fluids, tissues, and excreta of the body (effect of body on the drug).
ADME (T): is a term used for absorption, distribution, metabolism, excretion and toxicology studies.
Pharmacodynamics: study of the physiological effects of ingested drugs within or on the body. (effect of drug on the body).
Pharmacogenomics: study of how an individual's genetic constitution affects body's response to drugs.
Pharmaceutical Formulation: process in which different substances, including the active drug, are combined to produce a final medicinal product.
Biologics: studying a wide range of medicinal products of biological origin. Examples are vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. In most of the jurisdictions worldwide, biologics are regulated in a different manner than are drugs and medical devices.
Bioequivalence: United States Food and Drug Administration (FDA) has defined bioequivalence as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. These studies are mainly conducted to compare two products such as a commercially-available Brand product and a potential to-be-marketed Generic product.
Bioavailability: is the fraction of the administered dose that reaches the systemic circulation.
Potency and Efficacy: Potency refers to the amount of drug (usually expressed in milligrams) needed to produce an effect. Efficacy refers to the potential maximum therapeutic response that a drug can produce.
Dose Response: measured as LD50 or statistically-derived dose that is lethal to 50% of a modeled population.
Pharmacovigilance: is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications.
References:
1. Gibaldi, M. and Perrier, D. 1975 Pharmacokinetics, Marcel Dekker, page v.
2. J. Lazarou, B. H. Pomeranz, and P. N. Corey. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. Apr 15, 1998. 279(15):1200-5.
3. J. Hodgson, and A. Marshall. Pharmacogenomics: will the regulators approve? Nature Biotechnolgy. 16: 243-246. 1998.
4. S. Pistoi. Facing your genetic destiny, part II. Scientific American. February 25, 2002.
5. Genomics.energy.gov
6. Wikipedia (en.wikipedia.org)
7. accelrys.com
8. http://www.fas.org/ota/reports/7401.pdf
9. http://aquaticpath.umd.edu/appliedtox/dose-response.pdf
10. www.fda.gov
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