Quote: "The regulation of therapeutic goods, defined as drugs and therapeutic devices..."
Assessment and regulation of drugs, safety pharmacology, and toxicology in drug discovery.
Drug development process: This covers the entire process of developing a drug from research and preclinical testing to clinical trials and marketing authorization. It is essential to understand the drug development process to navigate regulatory and safety issues.
Pharmacokinetics and Pharmacodynamics: These are the study of how drugs interact with the body, how they are absorbed, distributed, metabolized, and excreted. This knowledge is necessary to understand drug safety and efficacy.
Toxicology: This is the study of the harmful effects of drugs and other chemicals on the body. Toxicology is essential in drug development and regulatory affairs to ascertain the safety of a drug before it is marketed.
Quality assurance and control: This entails ensuring that each step in the drug development process conforms to standards and that the final product is safe, effective, and consistent. Quality assurance and control are vital in ensuring compliance with regulations and minimizing risk.
Good Laboratory Practices (GLP): This is a set of standards that ensures the quality and reliability of laboratory studies. Understanding GLP is essential when conducting preclinical trials.
Good Clinical Practices (GCP): GCP is set of standards that ensures ethical and scientific quality in the design, conduct, recording, and reporting of clinical trials. Understanding GCP is necessary for regulatory compliance and ensuring patient safety.
Regulation and legislation: This encompasses the laws, guidelines, and regulatory bodies that oversee drug development and marketing. Understanding these regulations is vital to ensure compliance and avoid legal repercussions.
Risk assessment and management: This is the process of identifying, evaluating and minimizing risks associated with drugs. Understanding risk management is essential for ensuring patient safety, regulatory compliance, and minimizing financial losses.
Post-marketing surveillance: This involves monitoring the safety, efficacy, and quality of a drug after it has been approved and marketed. It is crucial in assessing potential long-term side effects and improving drug safety profiles.
Adverse events reporting and pharmacovigilance: This involves identifying, collecting and interpreting information on adverse events related to drugs. It is important in determining the safety and overall benefit-risk profile of a drug.
Drug safety: Safety concerns associated with drugs including side effect, drug-drug interaction.
Adverse drug reactions: Unwanted or harmful reactions that occur after the administration of drugs.
Quality control: The assurance of a standard level of quality for drugs and related substances.
Therapeutic equivalence: The ability of one drug to demonstrate the same therapeutic effect as another drug.
Pharmacokinetics: How drugs are absorbed, distributed, metabolized, and excreted in a body.
Drug interactions: Interactions that can occur between different drugs.
Drug metabolism interactions: The influence of one drug on another by altering its metabolism.
Drug-drug interactions: Interactions that can occur between drugs that affect the activity of enzymes or transporters in the body.
Drug food interactions: The interaction of drugs and food can have a significant effect on drug absorption.
Drug manufacturing: Good manufacturing process in producing drugs and ensuring its quality.
Drug approval: Ensuring that drugs and therapies are approved through the established regulatory body.
Drug pricing: The ethical and economic considerations in pricing new drugs.
Clinical trials: Ethical and legal requirements for clinical trials that involve human subjects.
Intellectual property: Intellectual property rights for drugs and new therapies.
Counterfeit drugs: Measures to prevent counterfeit drugs from entering the market.
Quote: "The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction."
Quote: "In some countries, such as the United States, they are regulated at the national level by a single agency."
Quote: "In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia."
Quote: "The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population."
Quote: "Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation."
Quote: "In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold."
Quote: "There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers."
Quote: "In some countries, such as the United States, they are regulated at the national level by a single agency."
Quote: "The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population."
Quote: "In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold."
Quote: "The regulation of therapeutic goods, defined as drugs and therapeutic devices..."
Quote: "In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia."
Quote: "There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers."
Quote: "Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation."
Quote: "The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population."
Quote: "In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia."
Quote: "Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation."
Quote: "The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population."
Quote: "In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold."