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Clinically Relevant Drug Product Specifications: Methods of Establishment

Clinically Relevant Drug Product Specifications: Methods of Establishment

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...

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

FDA Approved Drugs: Changes to Approved Drugs

FDA Approved Drugs: Changes to Approved Drugs

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,...

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...

Drug Dosage Regimen: Overview

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A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...

Dosage Regimen Designs: Nomograms and Tabulations

Dosage Regimen Designs: Nomograms and Tabulations

Nomograms and tabulations are vital tools used by clinicians to design accurate and individualized dosage regimens. These instruments provide a straightforward method for adjusting dosages based on individual patient characteristics, including age, weight, and physiological condition. The foundation of a drug's nomogram is population pharmacokinetic data collected and analyzed using specific models. This data simplifies complex equations, presenting them diagrammatically or tabularly for easy...

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Related Experiment Video

Updated: Dec 20, 2025

Curation of Computational Chemical Libraries Demonstrated with Alpha-Amino Acids

Curation of Computational Chemical Libraries Demonstrated with Alpha-Amino Acids

Published on: April 13, 2022

Evolution of the AMCP Format for Formulary Submissions.

John B Watkins¹, Sean D Sullivan², Elizabeth Sampsel³

¹Residency Program Director, Premera Blue Cross, Mountlake Terrace, Washington, and Affiliate Professor of Pharmacy, University of Washington, Seattle.

Journal of Managed Care & Specialty Pharmacy

|May 29, 2020

Summary

This study highlights the importance of the Format Executive Committee in scientific publishing. Authors, as committee members, ensure adherence to established formatting standards.

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Area of Science:

Scientific publishing standards
Editorial board roles

Background:

Authors disclose their affiliation with the Format Executive Committee.
No external funding was required for this project.

Purpose of the Study:

To outline the role and contributions of the Format Executive Committee.
To emphasize the self-funded nature of the project.

Main Methods:

Review of internal committee operations.
Analysis of author affiliations.

Main Results:

Authors' membership in the Format Executive Committee confirmed.
Project completed without external financial support.

Conclusions:

The Format Executive Committee plays a vital role in maintaining publishing integrity.
Internal resources and author commitment were sufficient for project completion.