Pharm cont. Final

Front: Role of Pharmaceutical Companies in Advancing New Therapies Back: Pharmaceutical companies conduct research, develop drugs, conduct clinical trials, and seek regulatory approval to bring new therapies to market.

Front: General Pathway from Drug Discovery to Marketplace Back: Involves drug discovery, preclinical testing, clinical trials (Phases 1-3), regulatory approval, and post-marketing surveillance.

Front: Key Stakeholders in Drug Development Back: Includes pharmaceutical companies, healthcare professionals, regulatory agencies, patients, and research institutions. They interact through collaboration, communication, and adherence to regulatory requirements.

Front: Definition of Bioethics Back: Bioethics involves the ethical issues and principles in biology and medicine. It is important in drug development to ensure ethical conduct, patient safety, and informed consent.

Front: Why and How Drugs are Identified for Development Back: Drugs are identified based on biological targets, disease understanding, and unmet medical needs.

Front: Unmet Medical Needs Back: Refers to medical conditions that currently lack effective treatments or have limited options.

Front: Common Methods for Screening Drug Candidates Back: Includes high-throughput screening, computer-aided drug design, and molecular modeling.

Front: High-Risk Nature of Drug Development Back: Drug development is high-risk due to high costs, long timelines, and uncertain outcomes.

Front: Why Drugs Cost So Much to Develop Back: High costs are due to extensive research, clinical trials, regulatory requirements, and failure rates of drug candidates.

Front: Preparing to Submit a New Drug Application (NDA) Back: Involves compiling data from preclinical and clinical studies, ensuring compliance with regulatory guidelines, and preparing detailed documentation.

Front: Major Components of an NDA Back: Includes preclinical data, clinical trial results, manufacturing information, labeling, and risk management plans.

Front: Understanding FDA Review and Approval Process Back: The FDA reviews the NDA for safety, efficacy, and quality. Approval is granted if the drug meets the necessary standards.

Front: Major Principles of Risk Management and Post-Approval Activities Back: Involves monitoring drug safety, reporting adverse events, and conducting additional studies as needed.

Front: Role of Payers in Evaluating Patient Access Back: Payers (insurance companies, government programs) evaluate drug cost-effectiveness and determine reimbursement policies.

Front: Pharmacovigilance and Ongoing Safety Monitoring Back: Continuous monitoring of drug safety after approval to identify and manage adverse effects.

Front: Role of Phase 4 Studies in Life-Cycle Management Back: Post-marketing studies to gather additional information on drug efficacy and safety.

Front: Legal and Regulatory Controls Over Marketing and Promotion Back: Regulations ensure truthful advertising, prevent misleading claims, and protect public health.