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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

249
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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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

734
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
734
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

222
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
222
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

314
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
314
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

279
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

344
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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Precision active pharmaceutical ingredients are the goal.

Andrew D Miller1,2

  • 1Institute of Pharmaceutical Science, Kings College London, Franklin-Wilkins Building, Waterloo Campus, 150 Stamford Street, London SE1 9NH, UK.

Future Medicinal Chemistry
|August 2, 2016
PubMed
Summary

This research explores chemical biology and organic chemistry to understand molecular recognition. The work aims to create precision active pharmaceutical ingredients (APIs) for treating chronic diseases with high target specificity.

Keywords:
antisense peptideschemical biologychemistry of stresscomplementary peptidesdiadenosine polyphosphatesdinucleoside polyphosphatesmolecular chaperonesprecision active pharmaceutical ingredientsprecision medicinesynthetic biologythioether fatty acids

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Area of Science:

  • Chemical biology
  • Organic chemistry
  • Molecular biology

Background:

  • Understanding molecular mechanisms is key to chemical biology.
  • Studies bridge molecular, nanomolecular, and whole-organism levels.
  • Precision medicine requires highly specific and selective active pharmaceutical ingredients (APIs).

Purpose of the Study:

  • To leverage organic chemistry and chemical biology for understanding molecular recognition.
  • To design and create novel precision APIs.
  • To develop potential treatments for major global chronic diseases.

Main Methods:

  • Utilizing an organic chemistry approach.
  • Applying chemical biology techniques.
  • Investigating biological molecular recognition processes.

Main Results:

  • Demonstrated understanding of molecular recognition.
  • Progress towards generating novel precision APIs.
  • Identified potential for treating chronic diseases.

Conclusions:

  • Academic research in organic chemistry and chemical biology is advancing precision API development.
  • This work shows promise for creating targeted therapies for chronic diseases.
  • Exploiting molecular mechanisms offers a pathway to highly specific and selective drug design.