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Clinically Relevant Drug Product Specifications: Methods of Establishment

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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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When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...

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Drug distribution in the body is intricately regulated by various physiological barriers that control the passage of substances. These include the capillary endothelial barrier, the blood-brain, blood-cerebrospinal fluid, blood-placental, and blood-testis barriers.
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Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System

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Considerations for setting occupational exposure limits for novel pharmaceutical modalities.

Jessica C Graham¹, Jedd Hillegass¹, Gene Schulze¹

¹Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ, 08903, USA.

Regulatory Toxicology and Pharmacology : RTP

|November 4, 2020

Summary

Pharmaceutical companies must adopt a modality-agnostic approach to drug development. This review offers occupational health and safety guidelines for handling novel therapeutic modalities, ensuring safe research, manufacturing, and administration.

Keywords:

Engineered bacteria Exposure control band Occupational exposure limit Occupational health Oncolytic virus PET Tracer Pharmaceutical modalities Protein therapeutic Vaccine safety Worker safety

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Area of Science:

Pharmaceutical Science
Occupational Health
Biotechnology

Background:

Advancements in biological understanding drive the development of novel therapeutic modalities for diverse diseases.
Emerging modalities like oligonucleotides, monoclonal antibodies, and vaccines offer breakthrough treatment potential.
Safe handling protocols are crucial for researchers, manufacturers, and healthcare professionals working with these new therapies.

Purpose of the Study:

To review the literature on emerging therapeutic modalities.
To provide occupational health and safety considerations for hazard identification and risk assessment.
To guide consistent and informed decision-making in hazard communication and risk management.

Main Methods:

Literature review of emerging therapeutic modalities.
Analysis of occupational health and safety requirements.
Evaluation of existing exposure control banding and occupational exposure limit systems.

Main Results:

Identified key emerging modalities including oligonucleotides, antibodies, peptides, and vaccines.
Highlighted the need for tailored hazard identification and risk assessment strategies.
Demonstrated limitations of traditional exposure control banding for certain biologics and oncolytic viruses.

Conclusions:

A modality-agnostic approach is essential for pharmaceutical development.
Established occupational exposure limit systems like Biosafety Levels are more applicable for certain novel agents.
Proactive risk management is critical for the safe integration of new therapeutic modalities into practice.