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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Bioequivalence: Overview01:16

Bioequivalence: Overview

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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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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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 indication due to...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...

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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Implications of biosimilars for the future.

Philip E Johnson1

  • 1H. Lee Moffitt Cancer Center, 12902 Magnolia Dr., Tampa, FL 33612-9497, USA. johnsonp@moffitt.usf.edu

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|July 18, 2008
PubMed
Summary

Biotechnology accelerates drug development for disease prevention and treatment. Pharmacists play a key role in clarifying terminology and science surrounding biotechnology products, including biosimilars, to aid decision-making.

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Area of Science:

  • Biotechnology in medicine
  • Drug product development

Background:

  • Biotechnology applications in medicine have a long history, with recent acceleration in new uses.
  • Biotechnology facilitates novel approaches for disease prevention, cure, and treatment.

Observation:

  • Diverse terminology exists for biotechnology products similar to reference products, such as biosimilars, follow-on biologics, and follow-on proteins.
  • Key biotechnology applications include recombinant DNA technology, monoclonal antibodies, and gene therapy.

Findings:

  • Pharmacy considerations for biopharmaceuticals encompass storage, handling, preparation, and administration.
  • The Food and Drug Administration (FDA) has not established a pathway for biosimilar therapeutic equivalence.
  • Payers may influence therapeutic equivalence decisions for cost-reduction purposes.

Implications:

  • Confusion surrounding biosimilars necessitates clear communication.
  • Pharmacists are crucial in educating policymakers and healthcare decision-makers on biotechnology processes and product implications.