How Radiosynthesis Supports Drug Development

How Radiosynthesis Supports Drug Development

The demand for radioisotopes in medicine is growing at a rapid rate, as radioactive compounds can be used as tracers to understand mass balance and metabolic profiles of drugs. Carbon-14 is a common radioactive isotope that’s used as a tracer in biochemistry methods such as DMPK and ADME studies.  

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The Purpose of Preliminary Testing for New Drugs

The Purpose of Preliminary Testing for New Drugs

The purpose of preliminary testing for new drugs is primarily to determine the safety and efficacy of potential substances, among many other drug characteristics along the way. Preliminary drug testing tests the safety and efficacy in three different phases. Each phase tests for various elements of safety and efficacy across increasing populations in order to obtain more data. Research institutions, big pharma companies, and pharmaceutical suppliers such as radiolabeled compounds suppliers rely on preliminary testing to ensure new drugs are safe and effective.   

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Pharmaceutical Manufacturing Safety Considerations

Pharmaceutical Manufacturing Safety Considerations

Every workplace presents a unique set of dangers. The pharmaceutical manufacturing industry presents many risks, from manufacturing-specific considerations to pharmaceutical safety hazards. While health and safety can often be difficult to maintain, the pharmaceutical industry must follow safety standards and regulations. From basic protections to highly specified pharmaceutical precautions, pharmaceutical manufacturing safety considerations cannot be overlooked. 

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The Importance of ISO Class 7 Cleanrooms

The Importance of ISO Class 7 Cleanrooms

A cleanroom is a controlled environment that has a low level of pollutants such as dust or chemical vapors. Cleanrooms are typically used in manufacturing or scientific research labs, such as a radiochemistry laboratory, where an ISO Class 7 cleanroom is required. The cleanroom classification standard ISO 14644-1 requires specific particle counts, such as ISO 7, to be met to classify the cleanliness level of a cleanroom or area.  

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Applications of GMP in Clinical Trials

Applications of GMP in Clinical Trials

When patients are administered medications, they trust that the doctor prescribing the drug has confidence in it. A doctor’s faith in a specific drug comes from trusting that the manufacturers used Good Manufacturing Practices (GMP) during clinical trials to ensure the quality and safety of the drug. A GMP certified manufacturer will follow these applications of GMP in clinical trials.  

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Characteristics of Radiopharmaceuticals

Characteristics of Radiopharmaceuticals

Radiopharmaceuticals are a drug grouping of unique medicinal formations. These formations use radioactive isotopes, also known as radioisotopes, in clinical diagnosis, as well as for therapeutic interventions. Common uses of radiopharmaceuticals in clinical diagnoses are to determine the functioning of the liver, lungs, and kidneys, blood flow to the brain, bone growth, the predictive effects of surgery, and to assess changes since treatment. Common uses of radiopharmaceuticals in therapeutic interventions are cancer and tumor treatment, thyroid disease, palliative treatment of bone metastasis, and arthritis.   

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Guide to the Drug Development Process

Guide to the Drug Development Process

The drug development process is the process of developing, testing, and approving a new drug for pharmaceutical usage. Before a new drug reaches a patient, it must go through five steps to determine if it is a safe and effective means of treating a specific condition. Follow this guide to the drug development process to understand what steps scientists need to take to get a drug out of the lab and into the patient’s hands. 

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3 Methods You Should Know About for Custom Radiolabeling

In the United States, there are approximately 810,000 people that work at chemical companies. That number includes those who are in the pharmaceutical sector. Custom radiolabeling is an important part of the work that’s done in creating new pharmaceuticals. When it comes to custom radiolabeling compounds, there are a variety of methods that can be used. Here are a few of the methods that can be helpful for preclinical or clinical studies.

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GMP Quality Assurance and Control: The Difference and Importance

Good Manufacturing Practice — GMP — is essential for ensuring that pharmaceutical products are produced according to the standards put in place by the FDA. These GMP standards are designed to help minimize the risk of contamination and harm to consumers. Today, technology has only helped to further improve these standards, with cleanrooms now able to maintain humidity at as close as a plus or minus 1% tolerance. Improvements such as these help ensure products aren’t compromised, both during testing and during storage.

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The Difference Between GMP and GLP Testing Lab Standards

Currently, the United States holds more than 45% of the total global pharmaceutical market. However, despite maintaining this foothold, there can still be confusion based on the differences between GMP and GLP testing lab standards and regulations. While both are testing laboratories, they are very different when compared and contrasted against each other.

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