Assignment1_Kriyesh Patel _Section10

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Feb 20, 2024

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Assignment #1 Kriyeshkumar Pravinbhai Patel Regulatory Affairs, Conestoga collage LAW8280: Regulation Theory and Design Ayu 02-02-2024

Describe the different stages of the drug development including Research & Development, Pre-clinical Research and Clinical Research Discovery and development: This is the initial stage of drug development, where scientists develop a product to either halt or reverse the effects of diseases. First of all, several molecule compounds are tested and selected as more effective and beneficial for further research. Once scientists find the perfect compound, they perform different experiments and collect information on the following hypotheses. 1) How the promising compounds absorb, distribute, metabolize, and dispose of waste. 2) The mechanisms of action and how they can help with future medical research. 3) The ideal dose for the future drug 4) The ideal route is to give or consume the drug, such as orally or injectable. 5) Side effects of the drugs and how it affects to individual of different ages and gender. (The Drug Development Process, 2019) Preclinical research: Before approval of any drug for human use, scientists must test its toxicity as a precautionary measure. This should be done in either vivo or in vitro form and must follow good laboratory practice, which is described in 21 CFR. It means that they need to set up basic requirements for personnel, facilities, equipment, written protocols, and operating procedures. This study is usually short and provides information about dosing and the overall toxicity level. (Mark Ilhan, 2022)

Clinical research: During the clinical research now teste on humans and observer how it will interact with human body. During the clinical trial developer follow protocol and specific study plan. They review the information about previous stages to develop research questions. 1) An eligibility requirement for participation 2) The timeline of study and the number of people allotted for it. 3) How and how much of the drugs will be taken. 4) Which evaluations and which information will be gathered. 5) How the gathered information will be examined and evaluated for upcoming phases of developing medicines. (Mark Ilhan, 2022) describe the pre-market regulatory requirements (including the application types): Cosmetic drugs: The manufacturer must ensure that the cosmetic is safe and effective for humans. Health Canada sets some safety rules through the Cosmetic Regulation Act as well as the Food and Drug Act. The drug must be free of contamination and have no harmful substances as per the label. Already, Health Canada has provided a list of substances that are prohibited or limited in cosmetics, known as the Cosmetic Ingredient Hotlist. Cosmetic drugs must be manufactured, stored, and packed on clean premises, and all manufacturers must follow good laboratory practices and good document practices. Officially, Health Canada does not approve the sale of drugs into Canada, and there is no pre-market requirement. However, all the cosmetic products sold in the Canadian market, whether locally

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