BIOPHAR - Definition of Terms for Biopharmaceutics

ABBREVIATED NEW DRUG APPLICATION (ANDA)

• refers to the formal submission made by drug manufacturers seeking approval to introduce a generic drug product into the market
• unlike the original brand-name drug, the generic manufacturer is exempted from conducting extensive clinical efficacy studies or nonclinical toxicology studies when preparing the

BIOAVAILABILITY

• refers to the measurement of the absorption rate and extent of the active ingredient or active moiety from a drug product, resulting in its availability at the intended site of action

BIOEQUIVALENCE REQUIREMENT

• is a mandate established by the FDA that necessitates the performance of in vitro and/or in vivo testing on specific drug products
• compliance with this requirement is a prerequisite for obtaining marketing approval

BIOEQUIVALENT DRUG PRODUCTS

• refers to pharmaceutical products that are either pharmaceutical equivalents or pharmaceutical alternatives and demonstrate comparable bioavailability when evaluated under similar experimental conditions

BIOSIMILAR / BIOSIMILARITY

• denotes a biological product that exhibits a high level of similarity to a reference product, with only minor variations in clinically inactive components
• there are no clinically significant differences between the biosimilar and the reference product in terms of the product's safety, purity, and potency

BRAND NAME

• refers to the distinctive trade name assigned to a drug by its manufacturer or distributor
• privately owned and serves the purpose of distinguishing the specific drug product from competing products in the market

DRUG PRODUCT SELECTION

• encompasses the procedure of carefully choosing or selecting specific drug in its appropriate dosage form
• this process involves considering various factors such as the patient's condition, the desired therapeutic outcome, and any relevant individual characteristics, in order to identify the most suitable drug product for a given situation

DRUG SUBSTANCE

• refers to the API or component present in a drug product that provides the pharmacodynamic activity
• it is the key chemical or biological substance responsible for producing the intended therapeutic effect when administered to the patient
• forms the essential core of the drug product, which may also contain other inactive ingredients or excipients

EQUIVALENCE

• refers to the relationship between two drug products in terms of bioavailability, therapeutic response or adherence to a set of predetermined standards
• indicates that the two products are comparable and can be expected to produce similar effects when administered under the same conditions
• can be assessed through various measures, including pharmacokinetic studies, clinical trials, and adherence to regulatory guidelines

GENERIC NAME

• refers to the established, nonproprietary, or common name assigned to the API in a drug product
• universally recognized name that is not owned by any specific manufacturer and is commonly used across different brands and formulations

GENERIC SUBSTITUTIION

• refers to the practice of dispensing a different brand or unbranded drug product as a replacement for the originally prescribed drug product
• the substituted drug product contains the same active ingredient or therapeutic moiety, typically in the same salt or ester form and dosage form, but is manufactured by a different company
• provide patients with a more affordable alternative while maintaining the same therapeutic effect

PHARMACETUICAL ALTERNATIVES

• refer to different drug products that contain the same therapeutic moiety, albeit in different salt, ester, or complex forms
• different dosage forms and strengths can also be considered

PHARMACEUTICAL EQUIVALENTS

• drug products that share identical dosage forms and contain the same active ingredient(s), specifically salt or ester form
• also characterized by having the same dosage form, utilizing the same route of administration, and being identical in strength or concentration
• the drug products are formulated to contain the same quantity of active ingredient in the same dosage forms nd comply with the same compendial or other applicable standards in terms of strength, quality, purity, and identity
• variations in non-essential characteristics (shape, scoring configuration, release mechanisms, packaging, excipients - colors, flavors, preservatives; expiration time, and labeling

PHARMACEUTICAL SUBSTITUTION

• refers to the practice of dispensing a pharmaceutical alternative in lieu of the prescribed drug product
• requires approval from the prescribing physician

THERAPEUTIC SUBSTITUTION

• practice of dispensing a therapeutic alternative as a replacement for the prescribed drug product
• may involve substituting one drug with similar therapeutic effects for another
• can also occur when a drug that has been approved by one NDA is substituted for another drug approved by a different NDA
• should be conducted under the guidance and approval of a healthcare professional to ensure the safety and efficacy of the substituted medication

REFERENCE LISTED DRUG (RLD)

• is a drug product identified by the FDA that serves as the basis for an applicant when seeking approval of an Abbreviated New Drug Application (ANDA)
• corresponds to the brand-name drug that has undergone a comprehensive New Drug Application (NDA) process
• designates (FDA) a SINGLE ____ as the established standard against which all generic versions must demonstrate bioequivalence - minimizes potential variations between generic drugs and their brand-name counterparts

THERAPEUTIC ALTERNATIVES

• refers to drug products that contain different active ingredients but are indicated for the same therapeutic or clinical objectives
• typically belong to the same pharmacologic class and are expected to produce similar therapeutic effects when administered to patients for a specific condition of use
• selection depends on various factors, including patient-specific considerations and potential contraindications or side effects

THERAPEUTIC EQUIVALENTS

• approved as safe and effective
• pharmaceutical equivalents
• bioequivalence
• adequate labeling
• current good manufacturing practice (cGMP) compliance
• THEY CAN BE SUBSTITUTED WITH THE EXPECTATION THAT THEY WILL PRODUCE THE SAME CLINICAL EFFECT AND SAFETY PROFILE AS THE PRESCRIBED PRODUCT