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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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Hormones can be classified into three main types based on their chemical structures: steroids, peptides, and amines. Their actions are mediated by the specific receptors they bind to on target cells.
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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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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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Bioidentical hormones.

F Z Stanczyk1,2, H Matharu1, S A Winer1

  • 1Departments of Obstetrics and Gynecology.

Climacteric : the Journal of the International Menopause Society
|January 6, 2021
PubMed
Summary
This summary is machine-generated.

Bioidentical hormone therapy (BHT) uses custom-compounded hormones, often perceived as natural. However, many BHT hormones are chemically identical to conventional therapies, and concerns exist regarding custom-compounded product safety and efficacy.

Keywords:
Bioidenticalcompoundingestrogenspostmenopauseprogesteronesalivary testing

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Area of Science:

  • Endocrinology
  • Pharmacology
  • Women's Health

Background:

  • Post-Women's Health Initiative trials, interest in alternatives to conventional hormone therapy (HT) has increased.
  • Custom-compounded steroid hormone preparations are a popular alternative, often termed 'bioidentical hormone therapy' (BHT).
  • Many patients perceive BHT hormones as natural, contrasting them with conventional HT's synthetic hormones, though chemical structures are often identical.

Purpose of the Study:

  • To address misconceptions and uncertainties surrounding bioidentical hormone therapy (BHT).
  • To clarify the relationship between salivary and serum/plasma steroid hormone concentrations.
  • To review the effects of topical progesterone on the endometrium, variability in compounded preparations, and FDA oversight.

Main Methods:

  • Literature review examining existing research on BHT, hormone measurement techniques, and regulatory guidelines.
  • Analysis of the chemical similarities between hormones used in conventional HT and BHT.
  • Evaluation of FDA regulations and concerns regarding custom-compounded products.

Main Results:

  • Many hormones in BHT are chemically identical to those in conventional HT, challenging the 'natural' versus 'synthetic' distinction.
  • Saliva testing for hormone customization is based on a misconception; salivary levels do not equate to free hormone levels in blood.
  • Concerns regarding the purity, potency, and quality of FDA-unapproved compounded hormones persist.

Conclusions:

  • Bioidentical hormone therapy (BHT) is chemically similar to conventional hormone therapy (HT).
  • Misconceptions about hormone equivalency and testing methods require clarification.
  • FDA oversight is evolving, aiming to improve the safety and efficacy of custom-compounded hormone preparations.