Reviewer-Psychopharmacology.pdf

1 PSYCHOPHARMACOLOGY REVIEWER L1: Introduction to Psychopharmacology Sensory Receptors Psychopharmacology 1. Chemoreceptors (Chemicals) - Comes from a classical Greek word "pharmakon"...

1 PSYCHOPHARMACOLOGY REVIEWER L1: Introduction to Psychopharmacology Sensory Receptors Psychopharmacology 1. Chemoreceptors (Chemicals) - Comes from a classical Greek word "pharmakon" 2. Thermoreceptors (Temperature) meaning Poison. Yet in Modern Greek, it means Drug. 3. Mechanoreceptors (Pressure) Logos of course means study. 4. Photoreceptors (Light) - It’s an interdisciplinary field combining psychology Examples with pharmacology and dealing largely with Receptor Stimulus psychotropic drugs, neurohormones, and Skin Touch & Temperature neurotransmitters. Tongue Chemicals in Drinks or Food Drugs Nose Chemicals in Air - Medication to treat a disease Eye Light - A chemical that can be abused - An exogenous chemical that significantly alters the Agonist function of certain bodily cells when taken in - A drug that binds to the receptor, producing a similar relatively low doses response to the intended chemical and receptor Psychoactive Drugs Natural Agonist - Many drugs of one class are used to treat disorders - Substances within the body that have evolved to previously assigned to another class produce a response when they bind to and “switch on” - Drugs from the categories are used to treat disorders a receptor. previously not treatable by drugs Agonist Drugs - Some non-psychiatric drugs can treat a variety of - They mimic natural agonists within the body, binding psychiatric disorders effectively but do not fit easily to receptors to create the same effect but often with a into traditional classification much more significant physiological response. - Some descriptive psychopharmacological terms Antagonist (blockers) overlap in meaning (e.g. Anxiolytics also have - A drug that binds to the receptor either on the primary sedative effects) site or on another site which all together stops the Other terminologies for Psychoactive Drugs receptor from producing a response 1. Psychopharmacologic Drugs Dose-Response Curve 2. Psychopharmacologic Medications - It is the relationship between drug dose and observed 3. Psychopharmacologic Treatment effect. 4. Psychopharmacologic Therapy - Low Dosage (Ineffectual) 5. Psychiatric Drugs - Effective Dosage/ED50 (Half-Maximal Response) 6. Psychiatric Medications - High Dosage (Lethal) 7. Psychotropic Drugs Types of Drug Tolerance 8. Psychoactive Drugs 1. Metabolic Tolerance - A biochemical tolerance that 9. Psychoactive Medications increases the metabolites such that they become less 10. Psychotropic Medications effective. Liver generally eliminates such metabolites Psychoactive Drugs Classifications before tolerance occurs. 1. Antipsychotics 2. Functional Tolerance - It leads to down-regulating 2. Antidepressants receptors in target neurons if an agonist continues to 3. Anxiolytics occupy neuronal environment. 4. Antimanic or Mood Stabilizers Other Drug Effects 5. Prescription Stimulants 1. Cross Tolerance - Tolerance to one drug that 6. Sedative-Hypnotics generalizes to other drugs 7. Miscellaneous Drugs 2. Sensitization - Drug craving caused by changes in the Drug Efficacy brain and receptor up regulation - The propensity of a drug to activate a receptor 3. Withdrawal Symptoms - Unpleasant cognitive sensation associated with drug cessation AIZAIH PADILLA 1 2 PSYCHOPHARMACOLOGY REVIEWER Types of Adverse Effects Guideline in the Selection of Drugs 1. Sexual Dysfunction 1. Diagnosis and identification of target symptoms 2. Anxiety 2. Drugs currently taken and recently discontinued 3. Akathisia 3. Suboptimal dosage of appropriate drugs 4. Insomnia Special Treatment Considerations 5. Gastrointestinal Upset 1. Geriatric Patients 6. Diarrhea - Susceptible to adverse effects 7. Headache - Slow metabolism 8. Anorexia 2. Children 9. Weight Gain - Small volume of distribution 10. Somnolence - Higher rate of metabolism 11. Dry Mouth 3. Pregnant and Nursing Women 12. Urinary Retention - Teratogenic Drugs (causes birth defects) 13. Constipation a. Lithium - birth anomalies such as Ebstein 14. Orthostatic Hypotension anomaly Discontinuation Syndrome b. Anticonvulsants - fetal craniofacial and - Transient emergence of mild symptoms upon the neural tube anomalies discontinuation or reduction of dosage. - Folic Acid (lowers the risks of teratogenicity) 4. Persons with Hepatic or Renal Insufficiency Drugs Drug Route Typical - may accumulate to toxic concentrations Administration Speed of - Reduced dosage, usually half the recommended dose effects - Monitor plasma drug concentrations Ingestion Tablets Slow to 5. Persons with Other Medical Illnesses Capsules Moderate - Increased sensitivity to adverse effects Syrups - Altered metabolism Infusions - Interactions with other medications Teas Suppositories Inhalation Smoking Moderate Nasal Absorption to Fast Inhaled Powders Sprays Peripheral Subcutaneous Moderate Injection Intramuscular to Very Intraperitoneal Fast (Abdominal) Intravenous Central Intracerebroventricular Fast to Injection (ventricular system) Very Fast Intrathecal (cerebrospinal fluid) Epidural (under durometer) Intracerebral (brain region) AIZAIH PADILLA 2 3 PSYCHOPHARMACOLOGY REVIEWER L2: Origins and Changes in Drug Use in the Society and Types of Drugs used Today Legal Aspects 1. Natural 2. Synthetic Where Does Drugs Come From? Drug Abuse Plants Animals Minerals - It is the use of any chemical substance, legal or illegal, resulting to individual's physical, mental, emotional Old-Fashioned Medicines impairment. Leaves Stem Forms of Drug Abuse Roots Seeds 1. Use of legal drugs without prescription or consultation Bulb Buds with physician. Blossoms 2. Use of legal drugs for a purpose different from what it was designed and prescribed for. Power Plants 3. Using drugs and substances without legitimate 1. Alkaloid - The most active component in plants, react medical application or purpose. with acids to form a salt that can dissolve more readily in body fluids. The names of alkaloids and their salts A comprehensive model of drug abuse should be able to usually end in “-ine.” answer the following questions: 2. Glycoside - Are also active components found in 1. What social and 2. What is addiction in plants. Names of glycosides usually end in “-in” such environmental factors behavioral and as digoxin. lead the individual to physiological terms, and 3. Gum - Constitute another group of active components. start abusing the drug? why is it so hard to quit? Gums give products the ability to attract and hold 3. What physiological 4. What factors makes one water. Examples include seaweed extractions and factors makes a continue? seeds with starch. substance rewarding? 4. Resin - The chief source is pine tree sap, commonly act as local irritants or as laxatives. Drug Models 5. Oil - Thick and sometimes greasy liquids, are 1. Moral Model - The abuser lacks morals and thus self- classified as volatile or fixed. Examples of volatile control. oils, which readily evaporate, include peppermint, 2. Disease Model - The drug abuser is diseased thus spearmint, and juniper. Fixed oils, which aren’t easily needs the drugs. Needs treatment rather than moral evaporated, include castor oil and olive oil. punishment. 3. Physical Dependence Model – The drugs are Animal Magnetism continued because their cessation causes unpleasant Hormones (Such as insulin) Oils and Fats (Usually withdrawal symptoms. fixed; such as cod-liver oil) 4. Positive Reward Model – It proposes that animals and Enzymes (Which are Vaccines (Which are humans engage in drug activity for its reward-like produced by living cells and suspensions of killed, consequences act as catalysts, such as modified, or attenuated Drug Dependence pancreatin and pepsin) microorganisms) - A state characterized by a compulsion to use a drug to experience psychological and physical effects. Mineral Springs Drug Misuse - Metallic and nonmetallic minerals provide inorganic - It is defined as the use of a substance for a purpose not materials not available from plants or animals. consistent with legal or medical guidelines (WHO, - The mineral sources are used as they occur in nature 2006). or are combined with other ingredients. - It has a negative impact on health or functioning and - Examples of drugs that contain minerals are iron, may take the form of drug dependence, or be part of a iodine, and Epsom salts. wider spectrum of problematic or harmful behavior (DH, 2006b) AIZAIH PADILLA 3 4 PSYCHOPHARMACOLOGY REVIEWER Individuals differ in their susceptibility to be becoming drug Types of Internets addicts because of many factors: 1. Internet – Infrastructure consisting of a standardized 1. Biological Factors - Men are more likely to abuse set of data transfer protocols for digital information drugs than women. exchange. 2. Family Situations - Family break-up, poor parental 2. Clear Web – Content indexed by standard web-search relationships, antisocial siblings lead to drug abuse. engines, accessible to anyone using the Internet. 3. Personal Characteristics - Aggressiveness and poor 3. Deep Web – Content not indexed by standard web- emotions. search engines; content can be located and accessed by 4. Environmental Factors - Prevalence of drug use in the a direct URL or IP address but may require a password community. or other security access to get past public-web-site pages; includes many very common uses such as web Social Issues linked to Drug Abuse: mail, online banking, private or otherwise restricted Drugged Driving Homelessness access content and profiles. Aggression Crime 4. Dark Web – Darknets or overlay networks within the Stress Missing Jobs Internet that can only be accessed with specific Child Abuse Job Retention Issues software, configurations, or authorization, and often use a unique customized communication protocol. World Drug Report 2023 (United Nations Office on Drugs a. Two typical darknet types are social and Crime) networks (usually used for file hosting with a 1. 1 in 17 people used drugs in 2021, up 23% from 2011 peer-to-peer connection), and anonymity 2. Opioids: main impact on disease burden; cannabis: proxy networks such as Tor via an most concern for disorders anonymized series of connections. 3. 13.2 million injected drugs in 2021, 18% increase Current Trends in The Philippines 2023 (Dangerous Drugs from 2020 Board) 4. Treatment barriers persist, especially for women 1. 82 Drug Abuse Treatment and Rehabilitation 5. Main death causes: hepatitis C liver diseases, opioid Centers (DATRCs) are reporting to the TRAIS system overdoses (75 residential, 7 outpatient). 6. Youth more vulnerable to drug use than adults 2. 5,546 total admissions recorded (4,425 new, 85 7. Prolonged surge in cocaine supply and demand readmissions, 1,036 outpatient). 8. Methamphetamine expanding beyond traditional 3. 43.49% increase in admissions compared to the markets previous year. 9. Complex drug-conflict relationship 4. 35.05% voluntary submissions, 27.71% plea 10. Displaced populations: higher risk of mental health bargaining cases. and substance use disorders 5. Demographics: 11. New cannabis-related substances emerging a. 91.74% male, 7.70% female, 0.56% LGBT 12. Synthetic drugs altering markets and supply chains b. Age range: 12-68 years (mean and median: 13. Non-medical tramadol use crisis in parts of Africa and 35 years) Asia c. 52.07% single, 23.26% married 14. Ketamine potentially becoming mainstream in some d. 26.96% attained high school education groups 6. Average monthly family income: Php 13,201.05 15. New Psychoactive Substances increased in 2021 after (US$237.60) stabilization 7. Employment: 57.90% employed, 37.88% 16. Digital interconnectivity: shorter supply chains, lower unemployed. costs, increased accessibility 8. 26.11% of cases from National Capital Region, 17. Medical cannabis regulations vary, potentially 12.93% from Region IV-A. affecting public health 9. Drug use patterns: 18. Psychedelic policy and research raising new a. 41.96% first used drugs between ages 15-19 questions b. 39.04% use drugs 2-5 times a week, 26.27% monthly, 18.73% weekly AIZAIH PADILLA 4 5 PSYCHOPHARMACOLOGY REVIEWER Most Commonly Abused Drugs Possession of Possession of Use of illegal 1. Methamphetamine Hydrochloride (Shabu) 92.77% illegal drugs at drug drugs 2. Cannabis (Marijuana) 28.25% social gatherings paraphernalia at 3. Cocaine 0.61% social gatherings Note: Mono-drug use is still the nature of drug-taking; The Cultivation of Improper record- Unnecessary or administration routes are inhalation/sniffing and oral ingestion plants classified keeping of unlawful as dangerous transactions prescription of Local Legislations drugs involving illegal dangerous drugs Republic Act 9711: Food and Drug Administration Act of drugs and 2009 precursor - An act strengthening and rationalizing the chemicals regulatory capacity of the bureau of food and drugs (BFAD). List of Philippine Government Drug Agencies - The Bureau of Food and Drugs (BFAD) is hereby 1. Philippine Drug Enforcement Agency (PDEA) renamed the Food and Drug Administration (FDA). 2. Philippine National Police (PNP) – Anti-Illegal Drugs Objectives of the Act: Special Operation Task Force To enhance and To ensure the To provide 3. Bureau Of Customs (BC) – Customs Task strengthen the FDA’s monitoring coherence in the Group/Force in Dangerous Drugs And Controlled administrative and regulatory FDA’s regulatory Chemicals and technical coverage over system for 4. National Bureau of Investigation (NBI) – Anti-Illegal capacity of the establishments establishments Drugs Task Force FDA in the and products and products 5. Dangerous Drugs Board (DDB) regulation of under its under its 6. Food and Drug Administration (FDA) establishments jurisdiction. jurisdiction. and products Historical and Cultural Aspects of Man's Relationship with under its Addictive Drugs jurisdiction. 1. Psychoactive substances have historically been used in religious ceremonies, for medicinal purposes, and Republic Act 9165: Comprehensive Dangerous Drugs Act recreationally. of 2002 2. Earliest use of psychoactive plants dates back thousands - An act instituting the comprehensive dangerous of years (e.g., Amanita muscaria, peyote). drugs act of 2002, repealing republic act no. 6425, 3. Medicinal use of substances like opium has ancient roots otherwise known as the “Dangerous Drugs Act of (e.g., mentioned in Homer's Odyssey). 1972”. 4. Alcohol, nicotine, and caffeine became widely consumed - Republic Act No. 10640 further strengthened the "staple commodities" in many cultures. anti-drug campaign of the government, otherwise 5. Refinement of substances and new administration routes known as the Republic Act 9165. increased potency and potential for abuse. Unlawful Acts: 6. Abnormal substance uses patterns recognized since Importation of Sale, distribution, Manufacturing of antiquity; modern addiction medicine emerged in 17th- illegal drugs and and transportation illegal drugs and 18th centuries. precursor of illegal drugs precursor 7. Key figures in addiction studies: Benjamin Rush, Emil chemicals and precursor chemicals Kraepelin, Sigmund Freud. chemicals 8. 20th century: development of diagnostic classifications Illegal diversion Manufacture or Possession of and neurobiological research. of controlled delivery of drug- drug 9. Current understanding: addictive substances affect the precursor related equipment paraphernalia brain’s reward system and conditioning. chemicals and paraphernalia 10. Genetic factors interact with the environment in addiction susceptibility. AIZAIH PADILLA 5 6 PSYCHOPHARMACOLOGY REVIEWER 11. Evolution of terminology: "addiction" replaced older terms like "inebriety" in medical contexts. 12. Ongoing debates: definition of addiction vs. dependence, individual vs. substance responsibility, punishment vs. treatment. 13. Addiction is viewed as a complex illness influenced by cultural, social, psychological, and biological factors. L3: Introduction to Pharmacology and Neurotransmitters Pharmacology - Scientific study of the actions of drugs and their effects on a living organism. Neuropharmacology - Drug-induced changes in the functioning of cells in the nervous system Section 1: Pharmacology (Pharmacokinetics) Psychopharmacology - drug-induced changes in mood, thinking, and behavior Neuropsychopharmacology - Identify chemical substances that act on the nervous system to alter behavior that is disturbed because of injury, disease, or environmental factors Section 1: Pharmacology Drug action - Specific molecular changes when drug binds to particular target site Drug effect - Alterations in physiological or psychological functions Therapeutic Effect (+) - Desired physical or behavioral changes Routes of Administration Side Effect (-) Bioavailability - Other produced changes - The amount of drug in the blood that is free to bind at specific target sites to elicit drug action Absorption, Distribution and Binding - Drug transport across membranes via passive or transport proteins - Distribution is limited by selective barriers Inactivation and Excretion Biotransformation Pharmacokinetics - Chemical alteration of drug in the body (drug - “What the body does to a drug” metabolism) - Absorption, Distribution, Metabolism, and Excretion - Inactivation influences the intensity and duration of Pharmacodynamics drug effects - “What a drug does to the body” Excretion of Drugs are done thru: - Physiological and Biochemical Interaction (enzymes, - Action of liver metabolizing enzymes transporter proteins, receptors); Dose response and - Eliminated from the body with the urine or feces Tolerance - Some drugs are excreted in an unaltered form by the kidneys AIZAIH PADILLA 6 7 PSYCHOPHARMACOLOGY REVIEWER Section 1: Pharmacology (Pharmacodynamics) Drug Interaction Receptors 1. Physiological Antagonism - Two drugs that act in two - Protein molecules located on the cell surface or within distinct ways but interact in such a way that they cells that are the initial sites of action of biologically reduce each other’s effectiveness active agents 2. Additive - Outcome exceeds the effect of either drug Ligands alone - Defined as any molecule that binds to a receptor with 3. Potentiation - Combination of two drugs produces some selectivity effects that are greater than the sum of their individual effects Dose Response Curve - Evaluate receptor activity - Extent of biological or behavioral effect produced by a given drug concentration (dose) ED50 - Dose that produces half the maximal effect Drug Tolerance - Diminished response to drug administration after repeated exposure to that drug Cross-Tolerance - Development of tolerance to one drug can diminish the effectiveness of a second drug Potency - Example: Effective anticonvulsant dose of - Absolute amount of drug necessary to produce a phenobarbital: Patient who has a history of chronic specific effect alcohol >> patient who has not developed tolerance to - Effective Dose (ED50): Dose at which 50% of the alcohol population experience the maximal effect Note: Tolerance to morphine-induced hyperthermia: Animals Toxicity treated in the same environment shows much less hyperthermia - Amount of drug necessary to produce an unwanted than the latter, this indicates tolerance. side effect - Toxic Dose (TD50): Dose at which 50% of the population experience the toxic effect Therapeutic Index - (TI = TD50/ED50) AIZAIH PADILLA 7 8 PSYCHOPHARMACOLOGY REVIEWER Section 2: Nervous System Two types of cells in the nervous system: 1. Glial cells - Play a supportive role in the synaptic and electrical interactions- neurons nourishment; structural support; aid in removal of waste product and neuron insulation 2. Neurons - Play in electrical signaling and synaptic communication in the nervous system - Primary line of communication between its various parts - Made up of three parts o Dendrites (to receive nerve signals) o Soma (metabolic center; contains the nucleus) o Axon (send information away) Criteria for Neurotransmitters Present in the presynaptic Enough transmitter quantity terminals must be released Specific agonists and Terminates the action of the antagonists transmitter Central Neurotransmitters: Amino acids 1. Gamma-aminobutyric Acid (GABA) - Main inhibitory neurotransmitter in the CNS - Synthesized in the brain from Krebs cycle Chemical Signaling between Nerve Cells - Acts on binding to specific ionotropic or metabotropic 1. Synapse - Gap that forms at the junction between the receptors on both pre- and postsynaptic membranes axon of one neuron and the dendrite of another neuron - Prevents the brain from becoming overexcited 2. Presynaptic cell - Sender of signal 2. Glutamate 3. Postsynaptic cell - Receiver of signal - Dicarboxylate amino acid neurotransmitter with 4. Synaptic space/cleft - Space that allows chemical excitatory actions in the CNS signals to be transmitted - High concentrations in the brain and have excitatory Types of synaptic connections effects 1. Axodendritic synapses - Most common synapses in - Principal fast excitatory neurotransmitter the brain; axon terminal from the presynaptic neuron - Acts through either ionotropic (ligand-gated ion communicates with a dendrite of the postsynaptic cell channels) or metabotropic receptors 2. Axosomatic synapses - Synapses between a nerve 3. Acetylcholine terminal and a nerve cell body - Present throughout the nervous system 3. Axoaxonic synapses - One axon synapsing on the - First discovered neurotransmitter terminal of another axon - Released as a response to an action potential that How does chemical signaling work? moves along the motor neuron Neurotransmitters - Synthesized from choline and acetyl-CoA by choline - Endogenous chemicals in the human body that are acetyl transferase responsible for the transmission of nerve impulses - Used to regulate muscle movement between neurons and target cells across a synapse - Acts through either nicotinic (ionotropic ligand-gated ion channels) or muscarinic receptors (metabotropic receptors) AIZAIH PADILLA 8 9 PSYCHOPHARMACOLOGY REVIEWER Central Neurotransmitters: Monoamines Neurotransmitter Inactivation Dopamine Epinephrine 1. Enzymatic breakdown within or near the synaptic Norepinephrine Serotonin cleft Note: Each system is anatomically distinct and serves separate, - ACh, for the lipid and gaseous transmitters, and also but similar, functional roles for the neuropeptide transmitters 2. Reuptake of neurotransmitters by the axon terminal Dopamine from the synaptic cleft - Synthesized from Tyrosine amino acid ▪ precursor of - Glutamate and GABA and also for monoamine norepinephrine transmitters such as DA, NE, and 5-HT - Predominant catecholamine in the CNS 3. Uptake by nearby glial cells - “Pleasure chemical”: released when mammals receive a reward in response to their behavior - Play a role in motivation, reward processing, motor control - Schizophrenics have too much dopamine Norepinephrine and Epinephrine - Both a hormone and a neurotransmitter - NE is converted by phenyl ethanolamine-N methyltransferase - Plays an important role in conditions related to stress - Enables to stimulate heart rate, blood circulation and respiration - Been linked to mood, arousal, vigilance, memory, and stress Serotonin - Synthesized in two steps from Tryptophan - Regulates attention and other complex cognitive functions, such as sleep (dreaming), eating, mood and pain regulation - Too little serotonin has been shown to lead to depression and anger control How and where in the nerve cell are neurotransmitters manufactured? - Except for the neuropeptides, transmitters are synthesized by enzymatic reactions anywhere - Enzymes are shipped out in large quantities to the axon terminals - Neuropeptides: produced in cell body Synaptic transmission: In classical transmitter 1. Neuron fires an action potential 2. the depolarizing current sweeps down the length of the axon and enters all of the axon terminals 3. Large numbers of voltage-sensitive calcium (Ca2+) channels opens 4. increase in [Ca2+] → direct trigger for neurotransmitter release AIZAIH PADILLA 9 10 PSYCHOPHARMACOLOGY REVIEWER ADDITIONAL LEARNING MATERIALS Chemical Name Psychopharmacology - A name that details a drug’s chemical structure. - Study of how drugs affect mood, perception, thinking Street Name or behavior. - An alternative name applied to a recreational or abused - Field of study within biological psychology that substances. examines the relationships between psychological - Given by those who use, sell, or illegally make functioning, behaviors, and drugs. recreational drugs. Psychoactive Drugs - Drugs that affect mood, perception, thinking, or Drug Name Street Name behavior by acting in the nervous system. Amphetamines Bennies, black beauties Psychopharmacologists Benzodiazepines Candy, downers, sleeping - They must have knowledge of the nervous system and pills how psycho-active drugs alter nervous system Cocaine Coke, rock, crack functioning. Dextromethorphan (used in Robo, triple C - They can be a medical practitioner (MD) like a cough syrup) psychiatrist, or a scientist who studies psychoactive Marijuana Joint, blunt, weed drugs. Methamphetamine Meth, ice, crystal - They develop therapeutic drugs as well as study the MDMA Ecstasy, Adaam effects of drug addiction and dependency LSD Acid, blotter Behavioral Pharmacology Phencyclidine PCP, angel dust - The study of how drugs affect behavior. Neuropsychopharmacology Dose - The study of how drugs affect the nervous system and - Ratio of the amount of drug per an organism’s body how these nervous system changes alter behavior. weight (1.0g/kg) Pharmacotherapeutics Dose-effect curve/Dose-response curve - Drugs used for treating disorders. - Depicts the magnitude of a drug effect by dose Drug ED50 value - Administered substance that alters physiological - Represents the dose at which 50% of an effect was functioning. observed Instrumental Drug Use - ED stands for effective dose. - Using a drug to address a specific purpose. Potency Therapeutic Drug - Amount of drug used to produce a certain level of - Drug used to treat a physical or mental disorder. effect Recreational Drug Use - Describing a drug as “highly potent” means that drug - Using a drug entirely to experience the drug’s effects. effects occur at low doses. 3 Effects of Drugs Toxic Dose 1. Agonist – Increases the effects of a particular - The level of drug’s dose that causes unacceptable neurotransmitter system. adverse effects. 2. Antagonist – Decreases the effects of a particular Therapeutic Index neurotransmitter system. - Ratio of a drug’s toxic dose-effect curve value relative 3. Modulatory Effect – Modifies on how a to therapeutic dose-effect curve value. neurotransmitter system is functioning, like making it Certain Safety Index more or less sensitive. - A therapeutic index calculated by dividing a TD1 value Note: Drugs can exert more than one effect by an ED99 value. Trade Name/Brand Name Pharmacodynamics - A trademarked name a company provides for a drug. - The physiological actions of drugs Generic Name Pharmacokinetics - A nonproprietary name that indicates the classification - A drug’s passage through the body for a drug and distinguishes it from others in the same class. AIZAIH PADILLA 10 11 PSYCHOPHARMACOLOGY REVIEWER Pharmacogenetics External Validity - The study of how genetic differences influence a - Refers to how well study findings generalize beyond drug’s pharmacokinetic and pharmacodynamic effects the study conditions. Objective effects - Ability to extend findings beyond study conditions. - Pharmacological effects that can be directly observed Face Validity by others - Appearance of a test measuring what a researcher Subjective effects considers it to measure - Pharmacological effects that cannot be directly - Test appears to measure what a researcher considers it observed by others to measure. Dependent Variable Construct Validity - A study variable measured by a researcher - How well a study’s findings relate to the underlying Independent Variable (or predictor) theory of a study’s objectives. - Study conditions or treatments that may affect a Predictive Validity dependent variable - How well a model predicts treatment affects. Correlational Study - Ability of model to predict treatment effects. - Study in which an investigator does not alter the Teratogen independent variable, changes in study variables are - Substance harmful to a fetus. observed, and relationships are inferred. 2 Government agencies that regulate academic and Experimental Study industrial animal research in the United States (US): - Study in which investigators alter a study’s 1. U.S. Department of Agriculture (USDA) independent variable and observe changes in a 2. Public Health Service (PHS) dependent variable. The 3 Rs - Experiments can identify casual relationships between - A review process for animal research that considers an independent variable and a dependent variable. “replacement”, “reduction”, and “refinement”, to Placebo determine the necessity of using animals, minimum - Substance identical in appearance to a drug but number of animals needed, and procedures to physiologically inert. minimize pain and distress. Treatment Arms Ethical Cost - Number of treatments and doses provided to patients - Assessment that weighs the value of potential research described in a clinical study. discoveries against the potential pain and distress Clinical study reports experienced by research subjects. - Detailed summaries of a clinical study’s design and results. Informed Consent Single-blind procedure - Consent gained after a participant thoroughly - When researchers do not inform study participants understands a study’s procedures, possible gains, and which treatment or placebo they received. potential risks. Double-blind procedure - When neither participants nor investigators know the Stages of Therapeutic Drug Development treatment assignments during a study. Stage Purpose Open-label studies 1 Identify disorder to treat - Assignment of study treatments without using blinded 2 Drug synthesis procedures. 3 Biological experimentation Internal Validity 4 Focused screening methods - Control of variables with potential to influence a 5 Safety pharmacology dependent variable. 6 Clinical trials - Adequacy of controlling variables that may influence a dependent variable. High-throughput Screening - Rapid testing process involving a large number of experimental drugs AIZAIH PADILLA 11 12 PSYCHOPHARMACOLOGY REVIEWER Safety Pharmacology - The study of a drug’s adverse effects Clinical Trial - A government-approved therapeutic drug experiment in humans’ drug development - A multistep process of developing an effective, safe, and profitable therapeutic drug. Clinical Goals Dose and Participants Trial Duration Involved Phase Phase 1 Determine a Low; short Normally healthy drug’s adverse term volunteers effect Phase 2 Determination May be Participants with of therapeutic higher; disorder effectiveness short term Phase 3 Further Dose based Participants with Determination on results disorder, but from Phase more inclusive 2; long term Phase 4 Occurs after Dose based Participants with the FDA on results disorder, focused approves a from Phase on unique effects drug for the 3; long in different market term populations AIZAIH PADILLA 12