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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

160
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

181
Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.
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Bioequivalence: Overview01:16

Bioequivalence: Overview

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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¹H NMR Chemical Shift Equivalence: Homotopic and Heterotopic Protons01:03

¹H NMR Chemical Shift Equivalence: Homotopic and Heterotopic Protons

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Protons in identical electronic environments within a molecule are chemically equivalent and have the same chemical shift. The replacement test is a useful tool to identify chemical equivalence and predict NMR spectra. A substituent replaces each of the protons being examined and the resulting molecules are compared. If the same molecule is obtained, the protons are equivalent or homotopic. Replacement of any hydrogens in ethane by chlorine yields chloroethane because all six protons are...
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Principle of Equivalence01:18

Principle of Equivalence

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According to Albert Einstein (1897-1955), free-falling and feeling weightless are intrinsically linked. If a person were in free-fall under gravity, for example, diving towards the Earth from an airplane, they would feel completely weightless. Similarly, a person descending in a lift may feel partially weightless. Broadly speaking, it is assumed that an object in a uniform gravitational field and an object undergoing constant acceleration in the absence of gravity are under the same...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Perceptual and Category Processing of the Uncanny Valley Hypothesis' Dimension of Human Likeness: Some Methodological Issues
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Not Really "The Same Thing".

Alison Schonwald1, Eugenia Chan2, Sarah S Nyp3

  • 1Developmental-Behavioral Pediatrician, Department of Pediatrics, Cambridge Health Alliance, Touchstone Neurodevelopmental Center, Harvard Medical School, Woburn, MA.

Journal of Developmental and Behavioral Pediatrics : JDBP
|December 5, 2019
PubMed
Summary
This summary is machine-generated.

A change in methylphenidate tablet appearance, despite pharmacy assurances, coincided with worsening attention-deficit/hyperactivity disorder (ADHD) symptoms in a 10-year-old girl. This highlights the importance of verifying medication formulation when treatment efficacy changes.

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Area of Science:

  • Pediatric neurology and developmental-behavioral pediatrics.
  • Pharmacology and medication management in children.
  • Behavioral therapy and treatment program efficacy.

Background:

  • A 10-year-old girl with combined type attention-deficit/hyperactivity disorder (ADHD) and challenging behaviors was treated with extended-release methylphenidate and guanfacine.
  • The patient had previously responded well to medication and behavioral therapy, including an 8-week summer treatment program.
  • Recent worsening of ADHD symptoms, including inattention and missed homework, occurred despite consistent home and school environments.

Observation:

  • Parents noted a change in the physical appearance of the methylphenidate tablets from oblong to round.
  • The pharmacy confirmed the medication was refilled with the same drug name but indicated a manufacturer change due to insurance formulary preferences.
  • Despite assurances, the change in tablet appearance and manufacturer raised concerns about potential formulation differences.

Findings:

  • The patient's classroom teacher reported increased difficulty with attention and distractibility.
  • Homework completion declined significantly over the past month.
  • The only reported change was the switch to a different manufacturer for the extended-release methylphenidate tablets.

Implications:

  • Investigate potential bioequivalence issues between different manufacturers of extended-release methylphenidate.
  • Consider the impact of pharmaceutical formulation changes on treatment effectiveness in pediatric ADHD.
  • Emphasize the importance of thorough medication reconciliation and patient/parent education regarding potential formulation variations.