DRUG DEVELOPMENT• Drug development is a blanket term used todefine the entire process of bringing a new drugor device to the Market.• It includes Drug discovery / productdevelopment, pre-clinical research(microorganisms/animals) and Clinical trials (onhumans).• Few people still refer to the drug development asmere preclinical development.
NEw ChEMiCaL ENTiTy (NCE)DEVELOPMENT• New Chemical Entities (NCEs) (also known as New MolecularEntities (NMEs)) are compounds which emerge from theprocess of drug discovery.• Have a promising activity against a particular biological targetthought to be important in disease; however, little will beknown about the safety, toxicity, pharmacokinetics andmetabolism of this NCE in humans.• A further major objective of drug development is to make arecommendation of the dose and schedule to be used the firsttime an NCE is used in a human clinical trial("first-in-man" )(FIM) or First Human Dose (FHD)).
CLiNiCaL TRiaLs• assess the safety and effectiveness of a new medication ordevice on a specific kind of patient.• assess the safety and effectiveness of a different dose of amedication than is commonly used.• assess the safety and effectiveness of an already marketedmedication or device for a new indication.• assess whether the new medication or device is more effectivefor the patients condition than the already used, standardmedication or device.• compare the effectiveness in patients with a specific disease oftwo or more already approved or common interventions for thatdisease.
CLiNiCaL TRiaL PhasEs• In Phase I trials, researchers test an experimental drug or treatmentin a small group of people (20-80) for the first time to evaluate itssafety, determine a safe dosage range, and identify side effects.
CliniCal trials• In Phase II trials, the experimental study drug or treatment is givento a larger group of people (100-300) to see if it is effective and tofurther evaluate its safety.
CliniCal trials• In Phase III trials, the experimental study drug or treatment is givento large groups of people (1,000-3,000) to confirm its effectiveness,monitor side effects, compare it to commonly used treatments, andcollect information that will allow the experimental drug or treatmentto be used safely.
CliniCal trials• In Phase IV trials, post marketing studies delineate additionalinformation including the drugs risks, benefits, and optimal use.
Phase iV CliniCal trial• Phase IV trial is also known as Post Marketing Surveillance Trial.• Phase IV trials involve the safety surveillance (pharmacovigilance)and ongoing technical support of a drug after it receives permissionto be sold.• The purpose of phase IV trials is to evaluate the side effects, risks,and benefits of a drug over a longer period of time and in a largernumber of people than in phase III clinical trials.
• Post-marketing research is an important element ofcommercialization that enables companies to expandexisting markets, enter new markets, develop and delivermessaging that directly compares their products with thecompetition, and secure a niche position in crowdedmarkets.
ADVERSE EVENTS• Adverse event (AE) is defined as thedevelopment of an undesirable medicalcondition or deterioration of re-existingmedical condition following or duringexposure to a pharmaceutical product,whether or not considered causally relatedto the product.
• AE can be symptoms, signs orabnormal results of an investigation(laboratory findings)• Can include undesirable medicalconditions during run-in or wash-outperiods of clinical studies, even if notreatment has been given yet.
AEs can be serious, hence called serious adverseevent (SAE) when it meets any of the followingconditions:• Results in death• Immediately life threatening• Requires in-patient hospitalization or prolongation of existinghospitalization• Results in persistent or significant disability or incapacity• A congenital abnormality/birth defect• Important medical event that may jeopardize the patient or mayrequire medical intervention to prevent the above stated conditions.
ADVERSE DRUG REACTION (ADR)• An unwanted or harmful reaction (AE) experiencedfollowing the administration of a drug or combination ofdrugs, and is suspected to be related to the drug• May be a known side effect of the drug or it may be newand previously unrecognized• Can be due to any therapeutic agent, includingprescribed and OTC drugs, blood products, vaccines,radiographic contrast media and herbal products
Why is it important to report andmonitor AEs?• safety profile of our drugs• benefit - risk profile of our products• prescribing and safety precautions• efficacy profile of our drugs