PHARMACEUTICAL PRODUCTS

WAYS IN WHICH DRUGS ARE TAKEN:

1. INHALATION2. INJECTION3.SUPPOSITORIES4. ORALLY

SIDE EFFECT:

A secondary effectUnwanted non therapeutic oneDue to taking the specific drug

EFFECTS ON THE FUNCTIONING BODY

alteration of incoming sensory sensationsalteration of mood or emotionsalteration of physiological state (eg.

consciousness, activity levels, physical coordination)

Placebo effect

MENTALSide Effects

COMMON:AggressionAgitationAnxietyConfusionDepressionHallucinationsHostileHyperactiveImpulsiveIrritablePanickyPersonality disorderOverly excitedSeverely restless (akathisia)Sleeplessness (insomnia)SuicideWeakness (asthenia)

MUSCULARSide Effects

COMMON:Back painLeg crampsMuscle painShakiness (tremor)SpasmTirednessSwelling of legs and feetUnexplained muscle painWeakness

ALLERGYSide Effects

COMMON:Serious allergic reactionsSwelling of the face, lips, tongue, and/or throatDifficulty breathingDifficulty swallowing

BLOODSide Effects

COMMON:AnemiaDecreased levels of potassiumDecreased levels of sodiumDizzinessExcessive bleeding (sometimes fatal)Facial flushingFainting (syncope)Fast heartbeat (tachycardia)Heart attackHigh blood pressure (hypertension)Increased levels of potassiumLow blood pressure (hypotension)Low blood cell countsPalpitationsPerpetual erection (priapism)Postural hypotensionSlow heartbeat (bradycardia)Thrombosis (clotting)

BONESide Effects

COMMON:Bone lossBone pain

Upper respiratory infection

PAINSide Effects

COMMON:Abdominal painBone painBreast painChest pain (angina)HeadacheHeartburnJoint painLeg crampsPainful menstruationVaginitis

SENSESSide Effects

COMMON:BlindnessBlurred visionColored visionRinging in the ears (tinnitus)Tingling sensation (paresthesia)

SKINSide Effects

COMMON:Allergic reactionItchingSkin rashSevere skin reactionsSweating

BRAINSide Effects

COMMON:AmnesiaDizziness (vertigo)SeizuresSpeech disorderStrokeTransient ischemic atychosisWorsening of epilepsy

GASTRO-INTESTINALSide Effects

COMMON:Abdominal painColitisConstipationDiarrheaDry mouthDyspepsiaIntestinal bleedingNauseaRectal bleedingStomach bleedingStomach painUpset Stomach (indigestion)Vomiting

LIVER/ KIDNEYSide Effects

COMMON:Acute kidney failureChronic kidney failureHepatitusJaundiceLiver damage

LUNGS (Pulmonary Side Effects) COMMON:

Cold symptomsCoughFlu-like symptomsLower respiratory infectionFluid in the lungs (pulmonary edema)Pulmonary thrombosisShortness of breath (dyspnea)Sore throat

3 DIFFERENT WAYS OF INJECTION:

1. INJECTABLES INTRAVENOUS (IV)injecting a liquid containing the drug directly into

veinsIt 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.

2. INTRATHECALInjected into the spinal cordThis directly delivers the drug to the central

nervous system

3. INTRAMUSCULARDrug is injected into the muscleA lot of rich blood present causing the drug

to go directly to the blood flow in the bodyAlso the nerves in the muscle cause

distribution in the nervous system

4. SUBCUTANEOUS(SC)Delivers drug below the fatty layer of skinNot painful because not a lot of blood or

nervesDistributes to the body slowlyCannot distribute large amounts of drugs

DRUG TOLERANCE

Occurs in chronic usersTakes a larger dose to achieve the same

resultIncreases the possibility of overdoseIncreases the side effectsDrugs suppress the central nervous system

and effect heart rate and breathing

THERAPEUTIC WINDOW

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 / windowtesting on humans in an initial clinical trial, on volunteers and

patience, half of which are given a placeboprocessing the product through other tests elaborating on

clinical situationshaving it approved by the drug administration, as either an OTC

(over the counter) drug or prescription drug

RESEARCH PROCESS

SafeEfficacioushas passed all regulatory requirementsDiscovery phaseClinical Testing

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.

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).

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.

TESTING

Bioanalytical TestingHelps support clinical testing Characterization of the moleculeHelps provide quality assurance and control

CLINICAL TRIALS

PHASE1PHASE2PHASE3

Testing on humans after testing on animals, with each phase the number of people increases to be tested

STAY DRUG FREE!