DRUG DEVELOPMENT• Drug development is a blanket term used to

define the entire process of bringing a new drug or device to the Market.

• It includes Drug discovery / product development, pre-clinical research (microorganisms/animals) and Clinical trials (on humans).

• Few people still refer to the drug development as mere preclinical development.

New Chemical Entity (NCE) development

• New Chemical Entities (NCEs) (also known as New Molecular Entities (NMEs)) are compounds which emerge from the process of drug discovery.

• Have a promising activity against a particular biological target thought to be important in disease; however, little will be known about the safety, toxicity, pharmacokinetics and metabolism of this NCE in humans.

• A further major objective of drug development is to make a recommendation of the dose and schedule to be used the first time 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 or device on a specific kind of patient.

• assess the safety and effectiveness of a different dose of a medication than is commonly used.

• assess the safety and effectiveness of an already marketed medication or device for a new indication.

• assess whether the new medication or device is more effective for the patient's condition than the already used, standard medication or device.

• compare the effectiveness in patients with a specific disease of two or more already approved or common interventions for that disease.

CLINICAL TRIAL PHASES

• In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its

safety, determine a safe dosage range, and identify side effects.

Clinical trials• In Phase II trials, the experimental study drug or treatment is given

to a larger group of people (100-300) to see if it is effective and to

further evaluate its safety.

Clinical trials

• In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Clinical trials

• In Phase IV trials, post marketing studies delineate additional

information including the drug's risks, benefits, and optimal use.

A VIEW OF PHASE IV CLINICAL TRIAL

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 permission to 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 larger number of people than in phase III clinical trials.

• Post-marketing research is an important element of commercialization that enables companies to expand existing markets, enter new markets, develop and deliver messaging that directly compares their products with the competition, and secure a niche position in crowded

markets.

PHASE IV CLINICAL TRIAL

ADVERSE DRUG EVENTS??

ADVERSE EVENTS

• Adverse event (AE) is defined as the development of an undesirable medical condition or deterioration of re-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

• AE can be symptoms, signs or abnormal results of an investigation (laboratory findings)

• Can include undesirable medical conditions during run-in or wash-out periods of clinical studies, even if no treatment has been given yet.

AEs can be serious, hence called serious adverse event (SAE) when it meets any of the following

conditions: • Results in death • Immediately life threatening • Requires in-patient hospitalization or prolongation of existing

hospitalization

• Results in persistent or significant disability or incapacity • A congenital abnormality/birth defect

• Important medical event that may jeopardize the patient or may

require medical intervention to prevent the above stated conditions.

ADVERSE DRUG REACTION (ADR)

• An unwanted or harmful reaction (AE) experienced following the administration of a drug or combination of drugs, and is suspected to be related to the drug

• May be a known side effect of the drug or it may be new and previously unrecognized

• Can be due to any therapeutic agent, including prescribed and OTC drugs, blood products, vaccines,

radiographic contrast media and herbal products

Why is it important to report and monitor AEs?

• safety profile of our drugs

• benefit - risk profile of our products

• prescribing and safety precautions

• efficacy profile of our drugs

DRUG PRODUCTS??

PHASE IV CLINICAL TRIAL

(POST-MARKETING SURVEILLANCE)

ADVERSE EVENTS REPORTING