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Key Attributes of an Ideal Clinical Trial Site: Essential Factors for Successful Research

Study sites for a clinical study are one of the most crucial factors for a successful research program. A suitable potential site for clinical trials is the study site that could be a medical facility, hospital or research institution that engages in clinical research programs. Any such facilities must possess suitable infrastructure and resources. This includes…

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Commonly Used Data Collection Methodology and Advantages of Data Collection in Clinical Trials

Clinical trial data is the final outcome of any clinical research program. The clinical research programs are primarily conducted to collect important health related information about the study participants and the influence of the intervention provided to the participants on a specific health related parameter. The clinical data supply arising from a clinical trial is…

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Exploring Essential Over-the-Counter Medications for Occasional Use: Your Guide to Safe and Reliable Options

OTC pharmaceuticals are those that can be purchased over-the-counter (OTC) without a prescription or seeking medical attention. Although OTC medicines are freely available in the market and can be easily purchased, it is essential that for proper use, people should adhere to the instructions on the "Drug Facts Label" on OTC medications. OTC medications can…

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Drug Review & Approval Process in Canada

Healthcare is a public welfare endeavor and all the governments across the countries strive for better healthcare facilities and policies for the citizens. One of the important attributes is to improve market access for various treatments and therapies at affordable costs. As the drug development is a long process once available, its accessibility for patients…

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Key Challenges and Solutions in Cryogenic Product Management

Cryogenics products contain cryogenic liquids that turn into gases under ambient temperatures. The word cryo- means “cold” and –genic means “producing”. Although cryogenic science is under the faculty of physics, it has wide applications in the field of medicine, materials science and electronics. Due to the changes in the state of matter with temperature change, the operations…

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ICH Multidisciplinary Guidelines

Drug development is primarily driven by three factors: quality, efficacy, and safety. The essential quality, nonclinical safety, and efficacy standards that are established by the assessment of the new drug's clinical efficacy and safety for its intended therapeutic indications in accordance with the ICH guidelines were covered in the previous few blogs. We'll concentrate on…

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Comprehensive Overview of ICH Safety Guidelines

To identify potential safety concerns such as unpleasant adverse effects of the medicines, ICH provides comprehensive guidelines that can be considered for therapeutic safety monitoring within the community. These safety guidelines are applicable during the non-clinical development of the new medicines. Safety assessment during the clinical trials and for the marketed medicines is considered under…

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Drug approval process in China

The People’s Republic of China is a huge pharmaceutical market and big pharma companies have been trying to get into the Chinese market for past few years. Recognising the need for new drugs for the people of China with an opportunity to develop indigenous industry, Chinese government over the years have made several policy changes to accelerate…

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ICH Quality Guidelines: What Every Pharmaceutical Professional Needs to Know

A global initiative called the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together powerful regulatory agencies from Europe, Japan, USA, and pharmaceutical companies to create guidelines and discuss the scientific and technical facets of developing pharmaceutical products and registering them. The goal of the ICH is to advance…

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