Drug Development Lifecycle, Patents, and Global Health Access

Pharmaceutical Research and Drug Development

6.1 Development of Medicines: Stages and Trials

The process of developing new medicines is typically divided into two main stages:

Stage 1: Discovery and Preclinical Trials

• This stage involves searching for substances that exhibit therapeutic activity against a disease while possessing minimal toxicity. This process is known as screening.
• Selected substances are subjected to in vitro tests. The most active candidates then undergo tests on animals to assess their response, efficacy, and safety profile.

Stage 2: Clinical Trials and Drug Safety Testing

The primary goal of this stage is to test the safety and efficacy of drugs in human subjects. It is conducted in four standard phases:

1. Phase I: Reviews safety and tolerance in a small group of healthy volunteers. Researchers determine how the drug is absorbed, metabolized, and excreted by the human body.
2. Phase II: Detects side effects and measures the drug's effectiveness in treating patients (usually a larger group than Phase I).
3. Phase III: Verifies the effectiveness of selected doses across a large patient population and gathers all necessary information to apply for regulatory approval from authorities.
4. Phase IV (Post-Marketing Surveillance): Once approved, the drug's efficacy, safety, and long-term side effects continue to be monitored.

6.2 Pharmaceutical Patents and Generic Drugs

A patent is an exclusive right of exploitation granted by a state for a discovery. It is typically valid for 20 years and allows the patent-holding company to generate revenue and profits.

Generic drugs are medications whose patent has expired. They use the original drug as a reference but are significantly cheaper. To be approved, generics must be tested for bioequivalence (ensuring they work the same way as the brand-name drug). The prescription of generics helps reduce overall healthcare costs.

6.3 Healthcare Challenges in Developing Nations

Healthcare systems in developing nations face significant challenges, including:

• Nature of Disease: Many countries still struggle with infectious diseases that have been largely eradicated in developed nations, alongside the rise of chronic diseases associated with unhealthy lifestyles.
• Lack of Healthcare Resources: Medical and nursing professionals often migrate to more developed areas. Healthcare provision in these regions is frequently dependent on foreign aid.
• Lack of Economic Resources: Many individuals lack access to necessary medical treatment due to the high cost of essential drugs.

Osteopathy and Chiropractic Practices

These complementary therapies are based on the principle that the body functions as a unified system. Practitioners utilize manual manipulation of the musculoskeletal system for diagnosis and treatment, aiming to address specific weaknesses and provide targeted pain relief.