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[Virtual Presenter] The drug development process begins with the discovery and development of a compound that can be transformed into a future medication. This initial step entails the examination of numerous compounds to identify a suitable therapy. Scientists conduct extensive tests on molecular compounds to uncover potential advantages against existing illnesses or newly emerging diseases. Additionally, they strive to uncover unforeseen consequences of current treatments. However, it's crucial to note that only a tiny fraction of these compounds will ultimately evolve into a viable treatment option..

[Audio] Researchers take the promising compound and conduct further experiments to gather more information. They investigate how the compound is absorbed, distributed, metabolized, and excreted in the body. They also study the potential benefits and mechanism of action of the compound, including determining the best dosage and method of administration. Additionally, they search for any side effects or adverse events, known as toxicity, and examine how the compound affects different groups of people, such as men and women, or individuals of different races or ethnicities. Furthermore, they assess the interaction between the compound and other medications or treatments, and compare its effectiveness to similar drugs..

[Audio] Approximately 25-30% of the drugs move to Phase 4, the final stage of clinical trials, where they are tested for long-term safety and efficacy. This phase involves several thousand volunteers who have the disease or condition being treated. The main purpose of Phase 4 is to gather more information about the drug's benefits and risks, including any rare or delayed side effects. The results of these studies are used to update the drug's label and ensure that patients receive accurate information about its use..

[Audio] The Investigational New Drug Process requires careful design and approval before clinical trials can begin. These trials involve individuals of all ages, including children. Prior to commencing the clinical phase, the company must initiate the Investigational New Drug Process and file the Investigational New Drug Application to secure regulatory approval. This process is mandatory, and no clinical phase can proceed without prior approval. The clinical research comprises four phases, ranging from Phase 1 to Phase 4..

[Audio] Animal study data provides valuable insights into the potential benefits and risks associated with a new compound. This includes data on the compound's ability to treat a particular condition or disease, as well as any potential side effects it may cause. Toxicity data, specifically, helps identify the maximum tolerated dose of the compound, which is crucial for determining its safety profile..

[Audio] Approximately 70% of drugs successfully progress to the next phase, known as Phase 2, also referred to as therapeutic exploratory trials, comprising volunteers with the disease or condition being targeted by the treatment. The main purpose of Phase 1 clinical trials is to evaluate the safety of the drug and the dosage, determining the maximum tolerated dose, pharmacokinetics, pharmacodynamics, and early measurement of drug activity. With 20 to 100 participants involved, the length of such studies typically spans several months, involving healthy volunteers without any disease or concurrent medications..

[Audio] Approximately one-third of the drugs that enter this phase will move on to the next step. This phase is crucial, as it helps us understand the safety and effectiveness of the drug, including any potential adverse reactions. By the end of this phase, we'll have a clear understanding of the drug's benefits and risks. Our study participants will consist of hundreds of people, and our studies will last anywhere from several months to two years. We're exploring the therapeutic efficacy and side effects of the drug. We're also determining the optimal dose and regimen for the next phase..

[Audio] Approximately 25-30 percent of the drugs move on to the next phase, known as Phase 4. This phase has a primary objective of ensuring the safety and efficacy of the drug. Thousands of volunteers who have the disease or condition being treated participate in these studies. The culmination of this phase is the submission of a New Drug Application, or NDA, to regulatory bodies. Prior to marketing the drug, the sponsor must submit the NDA, and marketing can only begin once approval is granted. The NDA provides a comprehensive overview of the drug's safety and effectiveness, demonstrating its suitability for its intended use in the studied population..

[Audio] After the drug has been approved, the sponsor is ready to bring it to market. This marks the beginning of post-market drug safety monitoring. As the drug enters the market, continuous vigilance is essential, and this is where the primary role of PV experts comes into play. If serious adverse events occur with increased frequency, the drug can be banned at any time. On the other hand, if only minor adverse events are reported, the drug will continue to be available in the market. Throughout this phase, additional new side effects may be noted due to the larger patient population, and the product label will need to be updated accordingly. Depending on the severity of these new adverse events, the drug may be withdrawn or banned..

[Audio] The micro dosing trials, also known as Phase 0 clinical trials, involve administering sub-pharmacological doses of a prospective drug to human volunteers, typically between 10 to 15 individuals. This study provides early Pharmacokinetic data in humans, offering insights into how the body processes the drug. Although this concept is a relatively recent innovation, there remains some uncertainty about whether these small doses can accurately determine the drug's Pharmacokinetic profile. The primary goal of Phase 0 is to gather Pharmacokinetic and Pharmacodynamic data on the drug, providing no information on safety and efficacy. Examples of drugs withdrawn from the market due to PV activity include Thalidomide, which was removed in 1965 due to cases of phocomelia..

[Audio] All drugs consist of two primary components: the Active Pharmaceutical Ingredient (API) and the excipient. The API is the central ingredient responsible for the therapeutic effect, whereas the excipient is a substance that assists in delivering the medication to the body. Excipients are chemically inactive and encompass substances such as lactose, mineral oil, and preservatives. For instance, examples of APIs include paracetamol, found in Crocin 650mg, and the active ingredients in vaccines like the Janssen COVID-19 Vaccine..

[Audio] The substances like lactose or mineral oil in pills, chemical exporters, colorants, or preservatives are added to create a final product. For instance, in Crocin 650mg, the active pharmaceutical ingredient is paracetamol, while the remaining components are excipients. Brand drugs, also known as innovator drugs, are medications sold by pharmaceutical companies under a specific name or trademark, protected by patents. These drugs may be available by prescription or over-the-counter. The original discoverer and developer of brand-name medicines submits a New Drug Application to the FDA, providing data on the product's characteristics, including dosage form, manufacturing, chemistry, stability, efficacy, safety, labeling, and packaging. This means that the drug we receive after clinical trials will be a branded drug, patented by the company that invested in conducting those trials..

[Audio] When new drugs are approved for marketing, they are patent protected. This means that only the sponsor has the exclusive right to market the drug until the patent expires. Once the patent expires, other drug manufacturers can develop the drug, which becomes known as a generic version of the original drug. These generic drugs are identical to brand-name drugs in terms of dosage, intended use, effects, side effects, route of administration, risks, safety, and strength. They are comparable to brand-name drugs and must meet the same standards for dosage form, strength, and safety..

[Audio] Generic drugs are comparable to brand drugs in terms of composition, except for the excipient part. They contain the same active ingredients and have the same therapeutic effects as brand-name drugs. However, generic drugs may differ in their appearance, such as color, shape, or size, due to differences in excipients. Because generic drugs are comparable to drugs already on the market, generic drug manufacturers do not need to conduct clinical trials to prove their product's safety and effectiveness. Instead, they conduct bioequivalence studies, also known as BE studies, to demonstrate that their product has the same performance characteristics as the original branded drug. These studies compare the pharmacokinetic and pharmacodynamic properties of the generic drug to those of the branded drug, ensuring that they have the same absorption, distribution, metabolism, and elimination profiles. After completing these studies, generic drug manufacturers submit an abbreviated New Drug Application, or ANDA, to market their generic drug..

[Audio] Bioavailability studies are used to assess the rate at which a drug enters the systemic circulation. Bioavailability studies compare the amount of active ingredient in a given dose of a drug that reaches the bloodstream. On the other hand, bioequivalence studies determine if two proprietary preparations of a drug are expected to produce the same therapeutic response. Bioequivalence studies compare the pharmacokinetic and pharmacodynamic properties of two different formulations of the same drug. Both studies are crucial in ensuring the safety and effectiveness of a generic drug product..

[Audio] Bioequivalence studies compare two drugs or two formulations of the same drug to ensure they have nearly equal bioavailability and pharmacokinetic/pharmacodynamic parameters. These studies are typically conducted for generic drugs or when a formulation of a drug is modified during development..