Drug Development Process Flashcards
(36 cards)
What are the phases of drug development ?
- Discovery and Development
- Preclinical Research
- Clinical Development
- FDA review
- FDA Post-Market Safety Monitoring
What is the Discovery in Discovery and Development?
This stage is generally the Target Discovery and Target validation stage.
What is the Development in Discovery and Development?
Once researchers identify a promising compound for development, they conduct experiments to gather information.
- Assay Development and Screening
- High Throughput Screening
- Hit to Lead
- Lead Optimization
- Active Pharmaceutical Ingredients.
What is Target Discovery and Target Validation
researchers discover new drugs through researching new insights of a disease that could stop or reverse the effect of a disease, this could also mean the testing of molecular compounds to see its benefits against a large number of disease. Discovery could also mean discovering ways of overcoming the existing treatments that have unanticipated effects and discovering new technologies that provide new ways to target or manipulate genetic material.
Validating the targets, researchers use modern tools and techniques such as diseases association or bioactive molecules or antibodies etc. Another way of validation is the Sanger Whole Genome CRISPER library.
What is Pre-Clinical Research
Researchers must determine the efficacy and the safety of the drug through in vivo research. Pre-clinical trails test the new drug on non-human subjects for efficacy, toxicity, and pharmacokinetics (PK) information, these trials are conducted by scientists in vitro and in vivo with unrestricted dosages.
What stages are included in Pre-clinical Research?
- Absorption, Distribution, Disposition, Metabolism and Secretion (ADDMS)
- Proof of Principle/ Proof of Concept
- In vivo, In vitro and Ex vivo Assays
- In Silico Assays
- Drug Delivery
What is ADDMS?
Absorption, distribution, disposition, Metabolism and Secretion is a Pharmacokinetic (PK) process of measuring the ways the new drug affects the body. It involves mathematical description of each effect.
What is Proof of Principle (PoP) or Proof of Concept (PoC)?
PoP are studies that are successful in preclinical trails and early safety testing. PoC is used almost interchangeably with PoP. Successful PoP/PoC studies lead to the programme advancement to the Phase II studies of dosage.
What are In Vivo, In Vitro and Ex Vivo Assays?
In Vivo - are the development of new drugs using mice, rats and dog models.
In Vitro - is research conducted in a laboratory.
Ex Vivo - uses animal cells or tissue from a non-living animals, research examples like finding effective cancer treatment reagents. In ex vivo assays, a cell is always used as the basis for small explant cultures that improve a dynamic, controlled and sterile environment.
What is In Silico Assay?
They are test systems or biological experiments performed on a computer or via computer simulation.
What is Drug Delivery?
New drug delivery includes oral, topical, membrane, intravenous and inhalation. they are used for target delivery or controlled release of new drugs. The goal is to prevent the drug from interacting with healthy tissues while still being effective.
What is Oral drug delivery?
They are reliable, cost-effective and convenient for patients. They may not deliver precise dosage to target area but is an ideal for prophylactic vaccinations and nutritional regimens. Delayed action, stomach enzyme destruction, absorption inconsistencies, or patients with gastrointestinal issues or upset can occur, and patients must be conscious during administration.
What is Topical Drug Delivery?
This involves ointments, creams, lotion, or transdermal patches that deliver a drug by absorption into the body. Topical delivery is more useful for patients skin or muscular condition, it is preferred by patients due to non-invasive delivery and their ability to self-administer the medicine.
What is Parenteral (IM, SC, or LP membrane) Drug Delivery?
Parenteral drug delivery utilizes bodily membranes, including intramuscular (IM), intraperitoneal (IP), or subcutaneous (SC). It is often used for unconscious patients and avoids epithelial barriers that are difficult for drugs to cross.
What is Parenteral (Intravenous) Drug Delivery?
Intravenous injection is one of the fastest drug delivery absorption methods. IV injection ensures entire dosage of drugs enters the bloodstream, as it is more effective than IM, SC, or LP membrane methods.
What is Parenteral (Inhalation) Drug Delivery?
Inhalation drug delivery gets the drug rapidly absorbed into the mucosal lings, nasal passage, throat, or mouth. Problems with inhalation delivery include difficulty delivering the optimum dosage due to small mucosal surface areas and patient discomfort. Pulmonary inhalation drug delivery uses fine drug powders or macromolecular drug solutions. Lung fluids resemble blood, so they can absorb small particles easily and deliver them into the bloodstream.
What is the Formulation Optimization & Improving Bioavailability in Drug Delivery?
Formulation optimization is ongoing throughout the pre-clinical and clinical stages. It ensures drugs are delivered to the proper place at the right time and in the right concentration.
What is Clinical Drug Development Process?
Once preclinical research is complete, researchers move to clinical drug development, including clinical trials and volunteer studies to fine-tune the drug for human use.
What stages/ phases are involved in the Clinical Process?
- Complexity of Study Design, Associated Cost & Implementation Issues.
- Clinical Trails - Dosage Escalation, Single Ascending & Multiple Dose Studies.
- Phase I - Healthy Volunteer Study,
- Phase II and III - Studies in Patient Population.
- Biological Samples collection, storage and shipment.
- Pharmacodynamic (PD) Biomarkers
- Pharmacokinetic Analysis
- Bioanalytical Method Development and Validation.
- Drug (analyte) & Metabolite Stability in Biological Samples
- Blood, Plasma, Urine & Feces Sample Analysis For Drug and Metabolites
- Patient Protection.
What is the Complexity of Study Design, Associated Cost & Implementation Issues?
This may affect the trails carried out in this phase. The trails must be safe and efficacious and be completed under the drug development budget, using a methodology to ensure the drug works as well as possible for its intended purpose.
What are the clinical trials?
This determines the proper dosing effectiveness and clinical trial examine dose escalation, single ascending and multiple-dose studies to determine the best patient dosage.
What is Phase I?
Phase I - the purpose of this phase is to test the safety and dosage. This phase is the first time the drug is tested on humans, less than 100 volunteers will help researchers assess the safety and pharmacokinetics, absorption, metabolic, and elimination effects on the body, as well as any side effects for safe dosage ranges.
What is Phase II?
Phase II - assesses the drug safety and efficacy in an additional 100-500 patients, who may receive a placebo or standard drug previously used as treatment. Analysis of optimal dosage strength helps create schedules while adverse events and risks are recorded. The purpose of this phase the Efficacy and side effects of the drug
What is Phase III?
Phase III - enrols 1000-1500 patients, enabling medication labelling and instruction for proper drug use. This phase requires extensive collaboration, organization and Independent Ethics Committee (IEC) or Institutional Review Board (IRB) coordination and regulation in anticipation of full-scale production following drug approval. The purpose of Phase III for efficacy and monitoring of adverse reactions.
