The 5 Phases of Drug Development | Rondaxe CMC Consulting
There are 5 essential milestones (phases) in the drug development process in the United States, each having stages within it. We will explore each of these phases and stages in detail to fully grasp the whole process.
Phase 1: Discovery and Development
New drugs are discovered through drug discovery. Since the sequencing of human DNA was implemented, reverse pharmacology has identified cures for existing ailments. Researchers then searched chemical libraries for small medicinal compounds, natural products or plant extracts.
Today's drug development incorporates hit screening, medicinal chemistry and hit optimization to limit adverse effects (increasing affinity and selectivity). This phase improves efficacy, potency, metabolic stability (half-life) and oral bioavailability.
Phase 2: Preclinical Research
Preclinical research determines the drug's effectiveness and safety after a lead chemical has been identified. The drug's researchers discover:
Information on absorption, distribution, metabolization and excretion
Benefits which may accrue and respective modes of action
The optimal dose and mode of delivery
Consequences and adverse events
Effects on certain racial, ethnic or gender groupings
Interactions with other therapies
Effectiveness in comparison to peer group medications
Preclinical studies examine the drug's effectiveness, toxicity and pharmacokinetics in non-human individuals. Scientists undertake unlimited dose studies in vitro and in vivo.
Phase 3: Clinical Research and Development
After preclinical research, researchers proceed to clinical medication development including clinical trials and volunteer studies.
Study Design Complexity, Cost and Implementation Issues
Trials must be safe, effective and conducted within the drug development budget. To be successful, this arduous approach requires a large number of volunteers. Contextual concerns and financial considerations can impact trials conducted during this period.
Phase 4: FDA Inspection
Upon the completion of clinical trials, the new medicine is submitted to the FDA for a comprehensive examination. The FDA now evaluates and approves or denies the drug developer's drug application.
Regulatory Approval Timeline
Depending on the application and patient need, a new drug's regulatory approval timeframe may be normal, breakthrough, expedited or priority. A year may be necessary if a standard review is applied; a breakthrough or expedited approval is quicker.
Phase 5: FDA Post-Market Safety Monitoring
The FDA mandates drug manufacturers to monitor medication safety using the FDA Adverse Event Reporting System (FAERS). Manufacturers, doctors, and patients use this service to report concerns with licensed pharmaceuticals.
Other Relevant Drug Development Concepts
Drug Master File
This contains private information on facilities, techniques or commodities used in producing, processing, packing and storing human drugs.
Drugs for Pediatric Use
Pediatric drugs are indicated for use in children and adolescents under 21. The AMA may make exceptions if a doctor and family agree on their use by an older adult.
Drugs for Veterinary Use
Veterinary drugs are meant for animals, pets and cattle. However, several veterinary medications are developed before becoming human or animal pharmaceuticals.
Small Molecule vs. Biologics
Small molecules have several biological activities. Large molecules (biologics) are therapeutic proteins. Small molecules signal cells; large molecular pharmaceuticals have around 1,300 amino acids.
Process Scale-up Differences and Issues
Changing procedures for various batch sizes can bring unanticipated challenges. Using the correct pharmaceutical equipment and identifying important process parameters can assist (CPPs).
Medication development aims to identify and supply new treatments which can enhance our health and well-being. New medication development is a highly regulated, complex procedure requiring highly skilled medical researchers. Human and animal clinical trial participants must be treated with the highest care.
To learn more about the drug development process, visit Rondaxe online or phone us in New York at (315) 469-2800 today.
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