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    Glossary Drug Approval Process

    rigorous steps to get new drugs approved by authorities

    The Drug Approval Process is a rigorous series of steps that a pharmaceutical company must follow to get a new drug approved for public use by regulatory authorities, such as the FDA in the United States. This process includes preclinical research, multiple phases of clinical trials to test safety and efficacy, and a thorough review of all data before the drug can be marketed.

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    1. Trypanocidal Effect of Isotretinoin through the Inhibition of Polyamine and Amino Acid Transporters in Trypanosoma cruzi PLoS neglected tropical diseases · 2017 · 41 citations
    2. Entrepreneurship in Off-Label Drug Prescription: Just What the Doctor Ordered! Social Science Research Network · 2015 · 3 citations
    3. High-content drug screening for rare diseases Journal of Inherited Metabolic Disease · 2017 · 29 citations
    4. The Necessity to Investigate In Vivo Fate of Nanoparticle-Loaded Dissolving Microneedles Pharmaceutics · 2024 · 14 citations
    5. Microneedles: Selected Applications for Pediatrics Children · 2026
    6. Controversies in off‐label prescriptions in dermatology: the perspective of the patient, the physician, and the pharmaceutical companies International Journal of Dermatology · 2018 · 8 citations
    7. Response of Hemiballismus to Haloperidol-Reply JAMA · 1976 · 1 citations
    8. SYNERGIA AI I MEDYCYNY: SZANSE I WYZWANIA Wiadomości Lekarskie · 2024
    9. Spotlight Commentary: Importance of dose redefining in the process of drug repurposing 2020 · 2 citations
    10. Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products The AAPS Journal · 2012 · 188 citations
    11. Drug Repurposing - Hypothesis, Molecular Aspects and Therapeutic Applications IntechOpen eBooks · 2020 · 39 citations
    12. 448 Challenges of securing insurance approval for oral tofacitinib treatment of alopecia areata: A multi-institutional retrospective review Journal of Investigative Dermatology · 2020
    13. Protein degradation: expanding the toolbox to restrain cancer drug resistance Journal of Hematology & Oncology · 2023 · 7 citations
    14. Hydrogel-Forming Microneedles in the Management of Dermal Disorders Through a Non-Invasive Process: A Review Gels · 2024 · 35 citations
    15. Ritlecitinib: First Approval Drugs · 2023 · 84 citations
    16. Antibody Drug Conjugates Oncology Times · 2020
    17. The role of biotransformation processes in mediating interactions between psychotropic drugs and natural products Journal of Mind and Medical Sciences · 2020 · 2 citations
    18. Prioritizing susceptibility genes for the prognosis of male-pattern baldness with transcriptome-wide association study Human genomics · 2024
    19. A machine learning and network framework to discover new indications for small molecules PLOS Computational Biology · 2020 · 8 citations
    20. Role of Drug Repurposing in Sustainable Drug Discovery IntechOpen eBooks · 2023
    21. Smart hydrogel dressings for advanced wound healing: from biomaterial design to microenvironment modulation Frontiers in Materials · 2026
    22. Current Protocols: Alopecia Areata Mouse Models for Drug Efficacy and Mechanism Studies Current Protocols · 2024
    23. Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database Expert Opinion on Drug Safety · 2024 · 1 citations
    24. Drug Repositioning: New Approaches and Future Prospects for Life-Debilitating Diseases and the COVID-19 Pandemic Outbreak Viruses · 2020 · 170 citations
    25. Nanocomposite patches for transdermal drug delivery: A review Science, Engineering and Health Studies · 2024 · 1 citations
    26. Lipid nanocarriers as innovative strategies for hair regrowth Discover Nano · 2026
    27. New treatments for rheumatoid arthritis Postgraduate Medicine · 1999 · 13 citations
    28. Clascoterone: First Approval Drugs · 2020 · 27 citations
    29. NANOPARTICLE-EMBEDDED MICRONEEDLES FOR ENHANCED TRANSDERMAL DELIVERY: ADVANCES AND APPLICATIONS International Journal of Applied Pharmaceutics · 2026
    30. Intestinal Lymphatic Biology, Drug Delivery, and Therapeutics: Current Status and Future Directions Pharmacological Reviews · 2024 · 9 citations