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Published byDrusilla Wade Modified over 9 years ago
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PHARMACEUTICAL PRODUCTS
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WAYS IN WHICH DRUGS ARE TAKEN: 1. INHALATION 2. INJECTION 3.SUPPOSITORIES 4. ORALLY
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SIDE EFFECT: A secondary effect Unwanted non therapeutic one Due to taking the specific drug
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EFFECTS ON THE FUNCTIONING BODY alteration of incoming sensory sensations alteration of mood or emotions alteration of physiological state (eg. consciousness, activity levels, physical coordination) Placebo effect
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MENTAL Side Effects COMMON: Aggression Agitation Anxiety Confusion Depression Hallucinations Hostile Hyperactive Impulsive Irritable Panicky Personality disorder Overly excited Severely restless (akathisia) Sleeplessness (insomnia) Suicide Weakness (asthenia) MUSCULAR Side Effects COMMON: Back pain Leg cramps Muscle pain Shakiness (tremor) Spasm Tiredness Swelling of legs and feet Unexplained muscle pain Weakness
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ALLERGY Side Effects COMMON: Serious allergic reactions Swelling of the face, lips, tongue, and/or throat Difficulty breathing Difficulty swallowing BLOOD Side Effects COMMON: Anemia Decreased levels of potassium Decreased levels of sodium Dizziness Excessive bleeding (sometimes fatal) Facial flushing Fainting (syncope) Fast heartbeat (tachycardia) Heart attack High blood pressure (hypertension) Increased levels of potassium Low blood pressure (hypotension) Low blood cell counts Palpitations Perpetual erection (priapism) Postural hypotension Slow heartbeat (bradycardia) Thrombosis (clotting) BONE Side Effects COMMON: Bone loss Bone pain Upper respiratory infection
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PAIN Side Effects COMMON: Abdominal pain Bone pain Breast pain Chest pain (angina) Headache Heartburn Joint pain Leg cramps Painful menstruation Vaginitis SENSES Side Effects COMMON: Blindness Blurred vision Colored vision Ringing in the ears (tinnitus) Tingling sensation (paresthesia) SKIN Side Effects COMMON: Allergic reaction Itching Skin rash Severe skin reactions Sweating
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BRAIN Side Effects COMMON: Amnesia Dizziness (vertigo) Seizures Speech disorder Stroke Transient ischemic atychosis Worsening of epilepsy GASTRO-INTESTINAL Side Effects COMMON: Abdominal pain Colitis Constipation Diarrhea Dry mouth Dyspepsia Intestinal bleeding Nausea Rectal bleeding Stomach bleeding Stomach pain Upset Stomach (indigestion) Vomiting
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LIVER/ KIDNEY Side Effects COMMON: Acute kidney failure Chronic kidney failure Hepatitus Jaundice Liver damage LUNGS (Pulmonary Side Effects) COMMON: Cold symptoms Cough Flu-like symptoms Lower respiratory infection Fluid in the lungs (pulmonary edema) Pulmonary thrombosis Shortness of breath (dyspnea) Sore throat
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3 DIFFERENT WAYS OF INJECTION: 1. INJECTABLES INTRAVENOUS (IV) injecting a liquid containing the drug directly into veins It is the quickest and most direct way of delivering a drug, and avoids the ‘first-pass effect’ The bolus of drug goes first to the heart and then to the general circulation.
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2. INTRATHECAL Injected into the spinal cord This directly delivers the drug to the central nervous system
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3. INTRAMUSCULAR Drug is injected into the muscle A lot of rich blood present causing the drug to go directly to the blood flow in the body Also the nerves in the muscle cause distribution in the nervous system
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4. SUBCUTANEOUS(SC) Delivers drug below the fatty layer of skin Not painful because not a lot of blood or nerves Distributes to the body slowly Cannot distribute large amounts of drugs
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DRUG TOLERANCE Occurs in chronic users Takes a larger dose to achieve the same result Increases the possibility of overdose Increases the side effects Drugs suppress the central nervous system and effect heart rate and breathing
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THERAPEUTIC WINDOW
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DRUG PROCESS isolating the new product from existing species (plants, animals) or synthesized chemically/artificially subjecting the product to laboratory and clinical pharmacological studies (plant and animal testing) to demonstrate its effectiveness testing its effective dosage (ED5O) and lethal dosage (LD50) rates establishing its therapeutic index / window testing on humans in an initial clinical trial, on volunteers and patience, half of which are given a placebo processing the product through other tests elaborating on clinical situations having it approved by the drug administration, as either an OTC (over the counter) drug or prescription drug
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RESEARCH PROCESS Safe Efficacious has passed all regulatory requirements Discovery phase Clinical Testing
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DEVELOPMENT When the candidate molecule shows promise as a therapeutic, it must be characterized—the molecule’s size, shape, strengths and weaknesses, preferred conditions for maintaining function, toxicity, bioactivity, and bioavailability must be determined. Early stage pharmacology studies help to characterize the underlying mechanism of action of the compound.
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Formulation, Delivery, Packaging Development Drug developers must devise a formulation that ensures the proper drug delivery parameters. It is critical to begin looking ahead to clinical trials at this phase of the drug development process, this can be refined many times Scientists determine the drug’s stability—in the formulation itself, and for all the parameters involved with storage and shipment, such as heat, light, and time. The formulation must remain potent and sterile; and it must also remain safe (nontoxic).
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Preclinical Toxicology Testing And IND Application Preclinical testing analyzes the bioactivity, safety, and efficacy of the formulated drug product. During the preclinical stage of the development process, plans for clinical trials and an Investigative New Drug (IND) application are prepared. Studies taking place during the preclinical stage should be designed to support the clinical studies that will follow.
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TESTING Bioanalytical Testing Helps support clinical testing Characterization of the molecule Helps provide quality assurance and control
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CLINICAL TRIALS PHASE1 PHASE2 PHASE3 Testing on humans after testing on animals, with each phase the number of people increases to be tested
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STAY DRUG FREE!
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