The document discusses quality by design (QbD) in pharmaceutical development. It defines QbD as a systematic approach that begins with predefined objectives and emphasizes product and process understanding based on science and risk management. Under QbD, the desired product performance profile, target product quality attributes, and critical material attributes are defined to identify and control sources of variability. QbD provides increased flexibility while maintaining quality standards compared to traditional quality testing approaches. Key aspects of implementing QbD include knowledge management, risk management, designing controls based on scientific understanding, and continual improvement using knowledge gained over a product's lifecycle.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
Quality must be built into the product, it cannot be inspected into it. The Pharmaceutical industries are experiencing a “knowledge and experience deficit” regarding the use of QbD concepts.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”Rajatmishra137
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
QBD Quality by design for Immediate release dosage formKushal Saha
Traditional approach of formulating a new drug product is an exhaustive task and involves a number of resources like man, money, time and experimental efforts. While, using this Quality by Design (QBD) approach one can get the pharmaceutical product of desired (best) quality with minimizing above resources as well as knowing the influence of one factor over the desired associated process. Hence aim of this study is the understanding of QBD approach to design product and manufacturing process to get desired pharmaceutical product. QBD follows the concepts of ICH guidelines (Q8, Q9 & Q10) which are essential for processing a pharmaceutical process. In this presentation we are going to focus upon QBD for immediate release dosage forms.
Quality must be built into the product, it cannot be inspected into it. The Pharmaceutical industries are experiencing a “knowledge and experience deficit” regarding the use of QbD concepts.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Pharmaceutical Quality by Design (QBD) is a concept introduced by the International Conference on Harmonization (ICH) Q8 guideline, as a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management.
The basic concept of QBD is “The Quality cannot be tested into the product, but it should be built into it.”
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”Rajatmishra137
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
A Review on Quality by Design and its Approachesijtsrd
The Pharmaceutical Quality By Design QBD is a systematic approach to the development that starts with the predetermined objectives and is based on the process of understanding process processes and process control, sound science and quality risk management. Quality Design QBD has been created to increase the assured of providing safe, effective medicines to customers and promised to make significant improvements in product quality performance. Supriya Khatal | Ashok Bhosale | Tejaswini Kande | Pallavi Dhekale | Punam Bramhadandi | Pratima Pokale "A Review on Quality by Design and its Approaches" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-6 , October 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29248.pdf Paper URL: https://www.ijtsrd.com/pharmacy/medicinal-chemistry/29248/a-review-on-quality-by-design-and-its-approaches/supriya-khatal
This is the seminar on Quality By Design (QbD) .
In this will discuss about Concept , Objectives, Benefits, Key Aspects of QbD.
Specially Design for a Seminar type Presentation.
Thank You , Keep reading and keep sharing.
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls,
manufacturing failure cost, scale up issues and regulatory burden in recent past suggest otherwise. In traditional quality by testing (QbT) approach, the product quality and performance are predominantly ensured by end product testing, with limited understanding of the process and critical process parameters. Regulatory bodies are therefore focusing on implementing quality by design (QbD), a science based approach that improves
process understanding by reducing process variation and the enabling process-control strategies. In this regards, pharmaceutical industry is currently undergoing a significant transformation to streamline their R&D process, provide greater manufacturing flexibility and control, and to reduce regulatory burden. However, there is limited understanding and major concerns regarding the implementation of QbD principles in the
pharmaceutical arena. The objective of this review article is therefore to provide a comprehensive understanding on various aspects of QbD, along with addressing the concerns related to its implementation.
The Pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
Quality cannot be tested into products; it has to be built in by design.
DEFINITION,PRINCIPLE, OBJECTIVES, ELEMENTS AND TOOLS OF QUALITY BY DESIGN (Qb...Durgadevi Ganesan
Quality by Design is a concept first outlined by Joseph M. Juran in various publications. He supposed that quality could be planned. The concept of QBD was mention in ICH Q8 guidelines, which states that, “To identify quality can not be tested in products, i.e. Quality should be built in to product by design.”
What is Quality by Design (QbD)?
Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products.
Why QbD?
Principle of QbD
Objectives of QbD
ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN:
- Quality Target Product Profile
- Critical Quality Attributes
- Product Design and Understanding
- Process Design and Understanding
- Process Design and Understanding
- Design space
- Control Strategy
- Continual Improvement
DESIGN TOOLS
- Prior Knowledge
- Risk Assessment
- Mechanistic Model, Design of Experiments, and Data Analysis
- Process Analytical Technology
“Current Approach of Quality by Design” An Overviewijtsrd
In this Analysis, well look at how QbD is being practised right now. QbD represents a cutting edge methodology for enhancing the safety and efficacy of pharmaceuticals. Quality by Design QbD is a relatively new idea in the pharmaceutical industry, but it has quickly become an integral aspect of the current approach to quality. Quality by Design relies on the ICH Guidelines as its basis. Guidelines Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality Systems from the International Council for Harmonization ICH served as inspiration for this document. QbD is the most effective method now available for improving the quality of all pharmaceutical goods, but it poses a significant problem for the pharmaceutical business, whose procedures are traditionally static. Eventually, despite inevitable process and material variation, It is crucial to establish the desired product performance profile Target product Profile TPP , Target Product Quality Profile TPQP and to pinpoint the attributes of quality that are most important to the products success throughout the QbD process CQA . We may then use this information to tailor the products composition and production method to those characteristics. This results in the identification and management of sources of variability and an understanding of the effect of raw materials critical material attributes CMA and critical process parameters CPP on critical quality attributes CQAs . To which the process and technique of development must have access. Quality by Design QbD encompasses the processes of drug development and manufacturing. that guarantees the product meets the standards set out in advance. R. Kavi Bharathi | R. Sanil Kumar | Shantaram Nangude "“Current Approach of Quality by Design” An Overview" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-1 , February 2023, URL: https://www.ijtsrd.com/papers/ijtsrd53873.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/53873/“current-approach-of-quality-by-design”-an-overview/r-kavi-bharathi
Research Article Published: "Optimization and formulation of dox loaded lipos...RAHUL PAL
Doxorubicin (DOX) is a potent anticancer drug, but it is also associated with significant side effects, such as cardiotoxicity. Liposomal encapsulation of DOX can help to reduce these side effects and improve the drug's efficacy.
There are a number of different factors that can affect the optimization and formulation of DOX-loaded liposomes, including:
Lipid composition: The type and ratio of lipids used to form the liposomes can affect their size, stability, and drug encapsulation efficiency. Some commonly used lipids for DOX liposomes include hydrogenated soy phosphatidylcholine (HSPC), cholesterol, and distearoylphosphatidylglycerol (DSPG).
Drug loading method: There are a number of different methods for loading DOX into liposomes. Some common methods include the ammonium sulfate gradient method, the remote loading method, and the ethanol injection method. The choice of loading method can affect the drug encapsulation efficiency and stability of the liposomes.
Liposome size: The size of the liposomes can affect their circulation time in the body and their ability to target specific tissues. Smaller liposomes tend to have a longer circulation time and are better able to penetrate tumors.
Surface modification: Liposomes can be surface-modified with various ligands to improve their targeting and delivery properties. For example, liposomes can be conjugated with antibodies to target specific cancer cells.
The optimization of DOX-loaded liposomes is typically carried out using a quality by design (QbD) approach. QbD is a systematic approach to drug development that focuses on identifying and controlling the critical quality attributes (CQAs) of the drug product. The CQAs of DOX-loaded liposomes may include particle size, drug encapsulation efficiency, stability, and in vitro and in vivo performance.
Similar to Pharmaceutical QbD concepts for drug development (20)
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MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.