Lists of pharmaceutical industry topics

From WikiMD's Food, Medicine & Wellness Encyclopedia

The pharmaceutical industry is a sector that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications. Pharmaceutical companies may deal in generic or brand medications and medical devices.

Drug Discovery and Development[edit | edit source]

Drug discovery and development is a complex process that involves biotechnological and pharmacological research to find new compounds with therapeutic potential.

Preclinical Research[edit | edit source]

Preclinical research is the phase where compounds are tested in vitro and in vivo to determine if they could become viable medications. This includes absorption, distribution, metabolism, and excretion (ADME) studies, toxicological testing, and pharmacodynamics and pharmacokinetics analysis.

Clinical Trials[edit | edit source]

Clinical trials involve multi-phase, systematic studies that include human subjects to test whether new drugs or treatments are safe and effective. Phases include:

  • Phase I: Testing on healthy volunteers for safety and dosage.
  • Phase II: Studies on patients to assess efficacy and side effects.
  • Phase III: Large-scale testing for safety, efficacy, and comparison with standard or equivalent treatments.
  • Phase IV: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

Regulation[edit | edit source]

The regulation of pharmaceuticals varies by jurisdiction but typically involves a Drug Regulatory Authority such as the FDA in the United States or the EMA in Europe, which oversee the approval of new drugs and monitor drug safety.

Market[edit | edit source]

The pharmaceutical market is influenced by a number of factors including patents, generic drugs, and pricing. Key topics include:

  • Patent Protection and Exclusivity: Legal protections that provide a temporary monopoly on a new drug.
  • Generics and Biosimilars: Versions of brand-name drugs that are allowed after patents expire.
  • Pricing and Reimbursement: How drugs are priced and paid for by health systems and individuals.

Ethical Considerations[edit | edit source]

The pharmaceutical industry faces various ethical considerations, including marketing practices, the impact of drug pricing on access to medications, and the ethical conduct of clinical trials.

Future of the Pharmaceutical Industry[edit | edit source]

Advancements in personalized medicine, Biopharmaceuticals, and Digital Health are transforming the industry, alongside the challenges of global Pandemics and Antibiotic Resistance.

List of Pharmaceutical Industry Related Topics[edit | edit source]

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Contributors: Prab R. Tumpati, MD