Drug Development Clinical Trial
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A Drug Development Clinical Trial is a Clinical Trial that is conducted to test, approve, and a follow-up a new pharmaceutical drug.
- AKA: Investigational New Drug (IND) Clinical Trial.
- Context:
- It (typically) requires regulatory approval (e.g. FDA approval via an Investigational New Drug Application or an Emergency Investigational New Drug Application).
- It can (typically) be preceded by a Drug Development Preclinical Trial.
- It can range from being a Phase-0 Clinical Trial to being a Phase-IV Clinical Trial.
- It can range from being a Drug Bioavailability Clinical Trial to being a Drug Bioequivalence Clinical Trial.
- Example(s):
- NCT01552772: Safety and Tolerability Trial of Aripiprazole IM Depot (Schizophrenia),
- NCT01424670: Safety and Efficacy Trial of Delamanid (Multidrug-resistant Tuberculosis),
- NCT03661983: Trial to Evaluate the Long-term Efficacy of Aripiprazole (Tourette's Disorder),
- NCT02020278: An Extension Follow-up Trial to Evaluate the Long-term Safety of Tolvaptan (Hyponatremia),
- …
- Counter-Example(s):
- See: Medical Treatment, Disease, Clinical Trial Phase, Illicit Drug, Orphan Drug, Generic Drug. Lead Compound, Drug Discovery, Preclinical Research, Food And Drug Administration, Investigational New Drug, Approved Drug, Regulatory Approval.
References
2022a
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Drug_development Retrieved:2022-1-15.
- Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process – from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials – to approved vaccine or drug typically takes more than a decade.
2022b
- (FDA) ⇒ https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#The_Investigational_New_Drug_Process Retrieved:2022-01-22.
- QUOTE: Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.
In the IND application, developers must include:
- Animal study data and toxicity (side effects that cause great harm) data;
- Manufacturing information;
- Clinical protocols (study plans) for studies to be conducted
- Data from any prior human research.
- Information about the investigator
- QUOTE: Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.
2009
- (Steinmetz & Spack, 2009) ⇒ Karen L. Steinmetz, and Edward G. Spack (2009). "The basics of preclinical drug development for neurodegenerative disease indications". In: Proceedings of the 2009 Drug Discovery for Neurodegeneration Conference, BMC Neurology 9(1).
- QUOTE: The drug development process is typically divided into three major steps: discovery, preclinical development, and clinical trial. The transition from discovery to preclinical development is a continuum, and results of preliminary pharmacology and toxicology testing often contribute to lead drug candidate selection. The boundary between preclinical development and clinical trial is sharply defined by the filing of an Investigational New Drug (IND; ...) application, which is required prior to initiation of the clinical trial. The activities supporting an IND application are the subject of this overview. The adage 'begin with the end in mind' is particularly appropriate for preclinical development, as the resulting IND must support the planned clinical trial design. For example, a clinical trial involving daily chronic administration requires repeat-dose toxicity studies in preclinical animal models.
Once a lead candidate is identified, a typical preclinical development program consists of six major efforts: manufacture of drug substance (DS)/active pharmaceutical ingredient (API); preformulation and formulation(dosage design); analytical and bioanalytical methods development and validation; metabolism and pharmacokinetics; toxicology, both safety and genetic toxicology and possibly safety pharmacology; and good manufacturing practice (GMP) manufacture and documentation of drug product for use in clinical trials (Figure 1) The IND application summarizes the results of the above activities for submission to the US Food and Drug Administration (FDA).
- QUOTE: The drug development process is typically divided into three major steps: discovery, preclinical development, and clinical trial. The transition from discovery to preclinical development is a continuum, and results of preliminary pharmacology and toxicology testing often contribute to lead drug candidate selection. The boundary between preclinical development and clinical trial is sharply defined by the filing of an Investigational New Drug (IND; ...) application, which is required prior to initiation of the clinical trial. The activities supporting an IND application are the subject of this overview. The adage 'begin with the end in mind' is particularly appropriate for preclinical development, as the resulting IND must support the planned clinical trial design. For example, a clinical trial involving daily chronic administration requires repeat-dose toxicity studies in preclinical animal models.