Drug Development And Approval Process
Expert-defined terms from the Certificate in Pharmacy Benefit Management course at London School of Planning and Management. Free to read, free to share, paired with a professional course.
Absorption refers to the process by which a drug is absorbed into the blo… #
This can occur through various routes, including oral, parenteral, or topical. Related terms include bioavailability, which refers to the proportion of a drug that enters the circulation when introduced into the body and so is able to have an active effect. The absorption of a drug can be affected by various factors, such as the formulation of the drug, the presence of food in the stomach, and the pH of the environment.
Active Pharmaceutical Ingredient (API) is the component of a drug that is… #
Related terms include excipient, which refers to an inactive substance that is added to a drug to aid in its manufacture, stability, or administration. The API is typically combined with excipients to create a formulation, which can take various forms, such as tablets, capsules, or solutions.
Adverse Event refers to any untoward medical occurrence that may present… #
Related terms include adverse reaction, which refers to an undesirable and unintended response to a drug that is related to its pharmacological properties. Adverse events can range from mild to severe and can be serious, meaning they result in death, hospitalization, or persistent disability.
Biopharmaceutical refers to a drug that is produced through biological me… #
Related terms include biotechnology, which refers to the use of biological systems or living organisms to develop new products or technologies. Biopharmaceuticals can include proteins, antibodies, and vaccines, which are used to treat a range of diseases and conditions.
Clinical Trial refers to a research study that is designed to evaluate th… #
Related terms include protocol, which refers to the plan or set of procedures that is used to conduct a clinical trial. Clinical trials are typically conducted in phases, with each phase designed to answer specific questions about the safety and efficacy of the drug. For example, Phase I trials are designed to evaluate the safety of a drug, while Phase III trials are designed to evaluate its efficacy.
Contract Research Organization (CRO) refers to a company that provides re… #
Related terms include outsourcing, which refers to the practice of contracting with an external organization to perform specific tasks or services. CROs can provide a range of services, including data management, statistical analysis, and regulatory affairs.
Data Management refers to the process of collecting, storing, and analyzi… #
Related terms include database, which refers to a collection of organized data that is stored in a way that allows for efficient retrieval and analysis. Data management is critical to the success of a clinical trial, as it allows researchers to track patient outcomes and monitor the safety and efficacy of the drug.
Drug Development refers to the process of discovering, testing, and comme… #
Related terms include research and development, which refers to the process of discovering and testing new ideas or products. Drug development is a complex and time-consuming process that involves multiple stages, including preclinical testing, clinical testing, and regulatory review.
European Medicines Agency (EMA) refers to the agency that is responsible… #
Related terms include regulatory agency, which refers to an organization that is responsible for enforcing laws and regulations related to the development and marketing of drugs. The EMA is responsible for reviewing applications for drug approval and monitoring the safety of approved drugs.
Fast Track refers to a program that is designed to accelerate the develop… #
Related terms include priority review, which refers to an expedited review process that is used for drugs that have been designated as priority products. The Fast Track program is designed to help speed the development and approval of drugs that have the potential to address unmet medical needs.
Food and Drug Administration (FDA) refers to the agency that is responsib… #
The FDA is responsible for reviewing applications for drug approval and monitoring the safety of approved drugs.
Generic Drug refers to a drug that is equivalent to a brand #
name drug in terms of its active ingredients, dosage form, and route of administration. Related terms include bioequivalence, which refers to the demonstration that a generic drug is equivalent to a brand-name drug in terms of its pharmacokinetics and pharmacodynamics. Generic drugs are often less expensive than brand-name drugs and can help increase access to affordable healthcare.
Good Clinical Practice (GCP) refers to a set of principles and guidelines… #
Related terms include quality assurance, which refers to the process of ensuring that clinical trials are conducted in accordance with established standards and regulations. GCP guidelines cover aspects such as informed consent, patient safety, and data management.
Investigational New Drug (IND) refers to a drug that is being investigate… #
Related terms include clinical trial, which refers to a research study that is designed to evaluate the safety and efficacy of a drug or treatment. An IND application is typically submitted to the FDA before a clinical trial can begin, and it must include information such as the protocol for the trial and the manufacturing process for the drug.
<B #
Labeling refers to the process of creating and reviewing the labels and packaging for a drug. Related terms include label claim, which refers to a statement that is made on the label of a drug about its indication, dosing, or side effects. Labeling is an important aspect of the drug development process, as it helps to ensure that patients and healthcare providers have access to accurate and clear information about the drug.
Managed Care refers to a type of healthcare system that is designed to co… #
Related terms include health maintenance organization (HMO), which refers to a type of managed care organization that provides healthcare services to its members. Managed care organizations often use formularies to help control costs and ensure that patients have access to effective and safe treatments.
New Drug Application (NDA) refers to an application that is submitted to… #
Related terms include regulatory submission, which refers to the process of submitting an application to a regulatory agency for the approval of a drug or treatment. An NDA must include information such as the chemistry of the drug, its manufacturing process, and the results of clinical trials that have been conducted to evaluate its safety and efficacy.
Off #
Label Use refers to the use of a drug for a purpose that is not approved by the FDA. Related terms include indications, which refer to the specific uses of a drug that are approved by the FDA. Off-label use can be common in certain fields, such as oncology, where drugs may be used to treat rare or serious conditions.
Orphan Drug refers to a drug that is intended to treat a rare disease or… #
Related terms include orphan, which refers to a disease or condition that affects fewer than 200,000 people in the United States. Orphan drugs are often eligible for special incentives and regulatory pathways that can help to speed their development and approval.
Over #
The-Counter (OTC) refers to a type of drug that can be purchased without a prescription. Related terms include prescription, which refers to a type of drug that can only be purchased with a valid prescription from a healthcare provider. OTC drugs are often used to treat common conditions, such as headaches or allergies.
Patent refers to a type of intellectual property that is granted to an in… #
Related terms include intellectual property, which refers to the legal rights that are granted to creators and inventors for their work. Patents can be used to protect the intellectual property of a company and help to ensure that it can recover its investment in the development of a new drug.
Pharmaceutical Benefit Management (PBM) refers to the process of managing… #
Related terms include formulary, which refers to a list of drugs that are covered by a health plan or PBM. PBMs often use formularies and utilization management techniques to help control costs and ensure that patients have access to effective and safe treatments.
Phase I Clinical Trial refers to the first stage of human testing for a n… #
Related terms include safety, which refers to the evaluation of the potential risks and benefits of a drug. Phase I trials are typically conducted in a small group of healthy volunteers and are designed to evaluate the safety and tolerability of the drug.
Phase II Clinical Trial refers to the second stage of human testing for a… #
Related terms include efficacy, which refers to the evaluation of the potential benefits of a drug. Phase II trials are typically conducted in a larger group of patients and are designed to evaluate the efficacy and safety of the drug.
Phase III Clinical Trial refers to the third and final stage of human tes… #
Related terms include confirmatory, which refers to the evaluation of the results of a clinical trial to confirm its findings. Phase III trials are typically conducted in a large group of patients and are designed to confirm the efficacy and safety of the drug and to evaluate its effectiveness in a real-world setting.
Pharmacokinetics refers to the study of the absorption, distribution, met… #
Related terms include pharmacodynamics, which refers to the study of the effects of a drug on the body. Pharmacokinetics is an important aspect of the drug development process, as it helps to understand how a drug is absorbed, distributed, and eliminated by the body.
Pharmacovigilance refers to the process of monitoring and evaluating the… #
Related terms include post-marketing surveillance, which refers to the process of monitoring the safety of a drug after it has been approved for use. Pharmacovigilance is an important aspect of the drug development process, as it helps to identify potential safety risks and to minimize harm to patients.
Pipeline refers to the portfolio of drugs that are currently in developme… #
A company's pipeline can include a range of drugs, from those in the early stages of development to those that are nearing approval.
Placebo refers to a dummy treatment that is used as a control in a clinic… #
Related terms include control group, which refers to the group of patients who receive a placebo in a clinical trial. Placebos are often used to evaluate the efficacy of a drug and to compare its effects to those of a placebo.
Preclinical Testing refers to the stage of testing that occurs before a d… #
Related terms include in vitro, which refers to testing that is conducted in a laboratory setting, and in vivo, which refers to testing that is conducted in a living organism. Preclinical testing is designed to evaluate the safety and efficacy of a drug and to identify potential risks and benefits.
Prescription Drug refers to a type of drug that can only be purchased wit… #
Related terms include over-the-counter, which refers to a type of drug that can be purchased without a prescription. Prescription drugs are often used to treat serious or chronic conditions, such as diabetes or hypertension.
Randomization refers to the process of assigning patients to different tr… #
Related terms include blinding, which refers to the process of hiding the treatment assignments from patients and healthcare providers. Randomization is an important aspect of the clinical trial process, as it helps to minimize bias and to ensure that the results of the trial are valid and reliable.
Regulatory Affairs refers to the process of interacting with regulatory a… #
Regulatory affairs professionals play a critical role in the drug development process, as they help to navigate the regulatory landscape and to ensure that a company's products are in compliance with relevant laws and regulations.
Regulatory Agency refers to an organization that is responsible for enfor… #
Related terms include Food and Drug Administration (FDA), which refers to the agency that is responsible for evaluating and approving drugs for use in the United States. Regulatory agencies play a critical role in the drug development process, as they help to ensure that drugs are safe and effective before they are approved for use.
Safety Surveillance refers to the process of monitoring and evaluating th… #
Related terms include pharmacovigilance, which refers to the process of monitoring and evaluating the safety of a drug after it has been approved for use. Safety surveillance is an important aspect of the drug development process, as it helps to identify potential safety risks and to minimize harm to patients.
Side Effect refers to an unwanted or unintended effect of a drug #
Related terms include adverse event, which refers to any untoward medical occurrence that may present during treatment with a pharmaceutical product. Side effects can range from mild to severe and can be serious, meaning they result in death, hospitalization, or persistent disability.
Specialty Pharmacy refers to a type of pharmacy that specializes in the d… #
Related terms include biopharmaceutical, which refers to a drug that is produced through biological means, such as through the use of living organisms or biotechnology. Specialty pharmacies often provide additional services, such as patient education and support, to help patients manage their conditions and to optimize their treatment.
Study Protocol refers to the plan or set of procedures that is used to co… #
A study protocol must include information such as the objectives of the trial, the design of the trial, and the methods that will be used to collect and analyze data.
Target Population refers to the group of patients that a drug is intended… #
The target population for a drug can be broad or narrow, depending on the specific indication and the patient population that is being targeted.
Therapeutic Area refers to a specific area of medicine or a specific type… #
Related terms include oncology, which refers to the study and treatment of cancer, and cardiology, which refers to the study and treatment of heart disease. Therapeutic areas can be broad or narrow, depending on the specific disease or condition that is being targeted.
Top #
Line Results refer to the primary outcomes of a clinical trial, such as the efficacy and safety of a drug. Top-line results are often released to the public and can be used to evaluate the potential of a drug and to inform investment decisions.
Vaccine refers to a type of biopharmaceutical that is used to prevent or… #
Related terms include immunization, which refers to the process of using a vaccine to prevent or treat an infectious disease. Vaccines can be inactivated, meaning they contain killed or inactivated pathogens, or live, meaning they contain live, attenuated pathogens.
refers to a foreign chemical substance that is found within an… #
Related terms include metabolism, which refers to the process by which the body breaks down and eliminates xenobiotics. Xenobiotics can be toxic or non-toxic, depending on their chemical structure and the way they interact with the body.