Fundamentals of Pharma

This post will dip into basic facts of how drugs are studied, major definitions within pharmacology, and how a medication eventually makes it to market.

Pharmacokinetics/dynamics

Pharmacokinetic interactions involve the absorption, distribution, metabolism, and excretion of drugs, while pharmacodynamic interactions involve the way a particular medication is influencing different body systems.

• Pharmacokinetics→movement and modification of medicine inside the body. (Medication: focus)
• Pharmacodynamics→the effects the medication has on the body. (Body: focus)
  • Medications with a narrow therapeutic index need to be closely monitored to prevent toxicity.
  • Medications with a wider therapeutic index are less dangerous, but can still be toxic.

Drug interactions may occur on both pharmacokinetic and pharmacodynamic levels. 

Nomenclature

Each medication has 3 names, which it receives during different stages on its way to market.

• Chemical Name (e.g. N-acetyl-para-aminophenol)
• Generic Name (e.g. Acetaminophen)
• Trade Name (e.g. Tylenol)

Drug Development Stages

There are three main stages of drug development and four phases of the last stage, which is clinical trials.

• discovery → The process of finding new drugs or compounds with potential therapeutic effects.
  • preclinical → Testing on cells and animals to assess a drug's safety and efficacy before human trials.
  • clinical trials → Relating to the observation and treatment of actual patients rather than theoretical or laboratory studies.
    • Phase I: Safety → Determining the safety of a drug in a small group of healthy individuals.
    • Phase II: Efficacy→Determining if the drug has the desired effect in patients with the condition being treated.
    • Phase III: Approval→Phase III clinical trials to assess the drug's effectiveness, safety, and appropriate dosage for FDA approval, comparing to current options.
    • Phase IV: Long Term→Long-term safety and efficacy studies in a larger patient population.

It can often cost millions in filing fees, tens of millions to complete research, and decades of development before a drug finally makes it to a consumer.