Pharmaceutical Equivalents. Drug products in identical dosage forms that contain the same active ingredient(s), ie, the same salt or ester, are of the same dosage form, use the same route of administration, and are identical in strength or concentration (eg, chlordiazepoxide hydrochloride, 5-mg capsules).
What are pharmaceutical equivalents?
Pharmaceutical Equivalents :FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: 1. they contain the same active ingredient(s) 2. they are of the same dosage form and route of administration 3. they are identical in strength or concentration
What is the difference between pharmaceutical equivalence and bioequivalence?
If there is pharmaceutical equivalence, it is likely there will be bioequivalence between two products. Bioequivalent products can be substituted for one another, and as a whole they show therapeutic equivalence to each other.
What is therapeutic equivalence?
Per the U.S. Food and Drug Administration (FDA), two medicines that have the same clinical effect and safety profile are said to have therapeutic equivalence. Contain the same active ingredient as the original medication.
Which drug products are therapeutically equivalent to the applicant's drug product?
Any drug product in the Orange Book repackaged and/or distributed by other than the applicant is considered to be therapeutically equivalent to the applicant’s drug product even if the applicant’s drug product is single source or coded as non-equivalent (e.g., BN).
What is meaning of pharmaceutical equivalent?
Pharmaceutical equivalents are drug products in identical dosage forms and route(s) of administration that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, or, in the case of modified-release dosage forms that require a reservoir or overage ...
What is the difference between pharmaceutical equivalent and therapeutic equivalence?
Therapeutic Equivalents: Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
What is bioequivalence and pharmaceutical equivalence?
Bioequivalence or pharmaceutical equivalence must be present showing that the two drugs release the active ingredient into the bloodstream at the same amount, the same rate, and have the same quality.
What is pharmaceutical equivalence Mcq?
Explanation: Pharmaceutic equivalence implies that two or more drug products when they are identical in strength, purity, content uniformity, and disintegration and dissolution characteristics. Though the excipients may differ.
What is the difference between bioavailability and bioequivalence?
Bioavailability studies focus on determining the process and time frame by which a drug substance is released from the oral dosage form and moves to the site of action. On the other hand, bioequivalence studies focus on the performance of the drug product and usually involve comparisons of two drug products: T and R.
What is example of therapeutic equivalence?
Therapeutic Equivalence: Examples. The FDA keeps a list (known as the Orange Book) of every approved therapeutic equivalent. One prescription example would be combined oral contraception, also known as the birth control pill.
What is pharmaceutical equivalence study?
Pharmaceutical equivalence – Drug products are considered pharmaceutical equivalents if they have the same active ingredients, the same dosage form and are identical in strength, quality, purity, and identity as the brand-name product, but they may differ in characteristics such as shape, packaging, and excipients ( ...
What is Orange Book in pharma?
publication Approved Drug Products with Therapeutic Equivalence EvaluationsThe publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and ...
What are the 2 types of bioavailability?
Types of bioavailability are as follow:Absolute Bioavailability: When the drug is administered through the intravenous route, the bioavailability of the drug achieved will be 100 percent. ... Relative Bioavailability: It is the bioavailability of the drug when obtained and it is compared with a reference standard.More items...
What is needed for bioequivalence?
Bioequivalence is achieved when the 90% confidence interval (CI) for the ratio of Cmax and AUC of the test product over the reference product on log transformed data is within 80%–125%.
What is bio equivalency?
Bioequivalency is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
What is drug bioavailability?
Bioavailability refers to the extent a substance or drug becomes completely available to its intended biological destination(s).
What is pharmaceutical equivalent?
What is pharmaceutical equivalence? Pharmaceutical Equivalent "Drug products are considered pharmaceutical equivalents if they contain the same active ingredient (s), are of the same dosage form, route of administration and are identical in strength or concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules). Click to see full answer.
What is the difference between pharmaceutical equivalent and therapeutic equivalent?
Keeping this in view, what is the difference between pharmaceutical equivalent and therapeutic equivalence? Two drug products are deemed to be pharmaceutical equivalents if they have the same active ingredient (s), strength or concentration, dosage form, and route of administration. Finally, 2 products are considered to be therapeutic equivalents ...
What is a pharmaceutical alternative?
The term pharmaceutical alternative as defined in the EU guideline (2) is used to define pharmaceutical products that have the same active moiety but that may differ in chemical form (i.e., salt, ester etc.) of that active compound or in dosage form or strength.
What is a drug?
A drug is defined as: A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.
What is a pharmaceutical equivalent?
Pharmaceutical Equivalents. Drug products in identical dosage forms that contain the same active ingredient (s), ie, the same salt or ester, are of the same dosage form, use the same route of administration, and are identical in strength or concentration (eg, chlordiazepoxide hydrochloride, 5-mg capsules).
What is a pharmaceutical substitution?
Pharmaceutical substitution. The process of dispensing a pharmaceutical alternative for the prescribed drug product. For example, ampicillin suspension is dispensed in place of ampicillin capsules, or tetracycline hydrochloride is dispensed in place of tetracycline phosphate.
Is tetracycline phosphate a pharmaceutical?
For example, tetracycline phosphate or tetracycline hydrochloride equivalent to 250 mg tetracycline base are considered pharmaceutical alternatives. Different dosage forms and strengths within a product line by a single manufacturer are pharmaceutical alternatives (eg, an extended-release dosage form and a standard immediate-release dosage form ...
What amendments required the Agency to publish an up-to-date list of all marketed drug products?
The Hatch-Waxman Amendments required the Agency to begin publishing an up‑to‑date list of all marketed drug products, OTC as well as prescription, that have been approved for safety and efficacy and for which new drug applications are required. Under the FD&C Act, some drug products are given tentative approvals.
What does "exclusion of a drug product from the Orange Book" mean?
Exclusion of a drug product from the Orange Book does not necessarily mean that the drug product is in violation of Section 505 of the FD&C Act, that such a product is not safe or effective, or that such a product is not therapeutically equivalent to other drug products.
When was Gaviscon approved?
A full NDA with clinical studies was submitted by Marion Laboratories, Inc., and approved by FDA on December 9, 1983. Gaviscon®’s activity in treating reflux acidity is made possible by the physical‑chemical properties of the inactive ingredients, sodium bicarbonate and alginic acid.
When was the drug price competition and patent term restoration act signed into law?
Each subsequent edition has included new approvals and made appropriate changes in data. On September 24, 1984 , the President signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).
Does the rate and extent of absorption of the drug show a significant difference from the rate and extent of absorption
the rate and extent of absorption of the [test] drug do not show a significant difference from the rate and extent of absorption of the [reference] listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses; or.
Is Orange Book drug equivalent to drug product?
Any drug product in the Orange Book repackaged and/or distributed by other than the applicant is considered to be therapeutically equivalent to the applicant’s drug product even if the applicant’s drug product is single source or coded as non-equivalent ( e.g., BN ).
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The Orange Book downloadable data files are updated monthly.
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The Orange Book downloadable data files are updated monthly.
What are some examples of therapeutic equivalents?
The FDA keeps a list (known as the Orange Book) of every approved therapeutic equivalent. One prescription example would be combined oral contraception, also known as the birth control pill.
What is the best way to make a drug a therapeutic equivalent?
For a drug to be approved as a therapeutic equivalent it must: Be safe and effective. Contain the same active ingredient as the original medication. Utilize the same route of administration. Be the same dosage. Meet the same standards for strength, quality, purity, and identity.
What is in vivo testing?
In vivo refers to when a test is done on the entire living organism, such as when a drug trial is conducted on human participants. Of note, these drugs do not need to have the same: Appearance (scoring, color, shape) Flavor. Packaging.
Pharmaceutical Equivalents
Pharmaceutical Alternatives
- Drug products that contain the same therapeutic moiety but as different salts, esters, or complexes. For example, tetracycline phosphate or tetracycline hydrochloride equivalent to 250 mg tetracycline base are considered pharmaceutical alternatives. Different dosage forms and strengths within a product line by a single manufacturer are pharmaceutical alternatives (eg, an …
Pharmaceutical Substitution
- The process of dispensing a pharmaceutical alternative for the prescribed drug product. For example, ampicillin suspension is dispensed in place of ampicillin capsules, or tetracycline hydrochloride is dispensed in place of tetracycline phosphate. Pharmaceutical substitution generally requires the physician’s approval.