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Rare Diseases: Pre-Clinical Studies And Clinical Trials In Orphan Drug Development

The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]

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Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-I

Regulatory approval process for Nutraceuticals/Complementary medicines in Australia

Do you wish to market your nutraceuticals/complementary medicines (vitamins, minerals, nutraceutical products, dietary supplements, and herbal products) in the Australian market? Then it is better to realize that the Australian regulatory requirements are different from other countries for such products. For example, in the United States of America (USA), by filing the GRAS status (Generally Recognized […]

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Rare Diseases: Clinical Trials & Drug Development

Rare disease drug development is a rapidly expanding field with growing pressure for getting a more orphan drugs approved to treat rare diseases. There is a vast consensus among patients, health care bodies, governments, etc. to expedite drug development in this field. Some wonderful numbers that attest to growing interest in rare diseases and orphan […]

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Thailand Latest Approved IRB List: Update 2

Thailand FDA periodically releases a list of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand’s regulatory system, approved ethics committees serve as the main point of approval for initiating clinical trials in the country. It has been explained in our previous articles (see Part I […]

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Clinical Trial Regulatory Process – Brazil

Brazil has grown exponentially in clinical research over the last decade. During the past 3 years, clinical trials in Brazil have grown significantly, with the country becoming one of the three most dominant emerging countries, along with India and Russia, which together attract the highest number of Western companies outsourcing clinical trials. Brazil is a […]

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What is the best EDC system / eCRF you’ve ever used? Review of online user-initiated surveys on social media

best_EDC_eCRF_systems_user_initiated_surveys_Credevo

A case record form (CRF) is a great and necessary tool used in clinical trials to collect data from each participating patient. CRF (also referred to as case report form) has historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper, where the sponsor can utilize one sheet for the Trial Master […]

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New Zealand – Clinical Trial Regulatory Process

New Zealand could be an interesting choice of region for national and international organizations seeking to pursue clinical trials and looking for the most preferred destination in the Asia-Pacific Region. The information in this article was last updated in Oct 2024. New Zealand, a country named the third most beautiful country in the world with stunning and […]

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Complicated Urinary Tract Infection & Acute Pyelonephritis – Clinical Trial Feasibility

A Complicated Urinary Tract Infection (cUTI), a severe class of UTI, one of the most common infections in the world, is notorious and recognized as a menace globally. cUTI has relapsing and refractory characteristics and is sometimes life-threatening because of patient predisposing factors as well as the recent worldwide spread of multi-drug resistant bacteria. Pyelonephritis – infections of the […]

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