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Academic Journal

New Horizons of Model Informed Drug Development in Rare Diseases Drug Development.

  • Authors : Mitra A; Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts, USA.; Tania N

Subjects: Rare Diseases*/Rare Diseases*/Rare Diseases*/drug therapy ; Drug Development*/Drug Development*/Drug Development*/methods; Humans

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Dec; Vol. 116 (6), pp. 1398-1411. Date of Electronic Publication: 2024 Jul 11.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper.

  • Authors : Sawant-Basak A; Clinical Pharmacology and Pharmacometrics, AstraZeneca, Waltham, MA, USA.; Urva S

Subjects: Drug Development*/Drug Development*/Drug Development*/legislation & jurisprudence ; Drug Development*/Drug Development*/Drug Development*/methods ; Pharmacology, Clinical*

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Oct; Vol. 116 (4), pp. 902-913. Date of Electronic Publication: 2024 Jul 07.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Quantitative Systems Pharmacology Models: Potential Tools for Advancing Drug Development for Rare Diseases.

  • Authors : Neves-Zaph S; Translational Disease Modeling, Translational Medicine and Early Development, Sanofi US, Bridgewater, New Jersey, USA.; Kaddi C

Subjects: Rare Diseases*/Rare Diseases*/Rare Diseases*/drug therapy ; Drug Development*/Drug Development*/Drug Development*/methods; Humans

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Dec; Vol. 116 (6), pp. 1442-1451. Date of Electronic Publication: 2024 Sep 28.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers.

  • Authors : Ahmed MA; Quantitative Clinical Pharmacology, Takeda Development Center, Cambridge, Massachusetts, USA.; Krishna R

Subjects: Drug Development*/Drug Development*/Drug Development*/methods ; Rare Diseases*/Rare Diseases*/Rare Diseases*/drug therapy; Animals

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Dec; Vol. 116 (6), pp. 1412-1432. Date of Electronic Publication: 2024 Aug 16.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Do You Want to Stay Single? Considerations on Single-Arm Trials in Drug Development and the Postregulatory Space.

Subjects: Drug Development*/Drug Development*/Drug Development*/methods ; Clinical Trials as Topic*/Clinical Trials as Topic*/Clinical Trials as Topic*/methods ; Research Design*

  • Source: Pharmaceutical statistics [Pharm Stat] 2024 Nov-Dec; Vol. 23 (6), pp. 1206-1217. Date of Electronic Publication: 2024 Jun 25.Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Simulation-based evaluation of the Pharmpy Automatic Model Development tool for population pharmacokinetic modeling in early clinical drug development.

  • Authors : Duvnjak Z; Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Basel, Switzerland.; Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universität Berlin, Berlin, Germany.

Subjects: Models, Biological* ; Drug Development*/Drug Development*/Drug Development*/methods ; Computer Simulation*

  • Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Oct; Vol. 13 (10), pp. 1707-1721. Date of Electronic Publication: 2024 Aug 18.Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Extended Model-Informed Drug Development: Beyond Clinical Trials and Regulatory Approval.

  • Authors : Kamal MA; Regeneron Pharmaceuticals, Tarrytown, New York, USA.; Ganguly S

Subjects: Drug Development*/Drug Development*/Drug Development*/methods ; Drug Development*/Drug Development*/Drug Development*/legislation & jurisprudence ; Drug Approval*

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Sep; Vol. 116 (3), pp. 518-521. Date of Electronic Publication: 2024 Jul 15.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program.

Subjects: United States Food and Drug Administration* ; Drug Development*/Drug Development*/Drug Development*/legislation & jurisprudence ; Drug Development*/Drug Development*/Drug Development*/methods

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Aug; Vol. 116 (2), pp. 282-288. Date of Electronic Publication: 2024 Mar 22.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Application of Model-Informed Drug Development in Dose Selection and Optimization for siRNA Therapies.

  • Authors : Yuan Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.; Li L

Subjects: RNA, Small Interfering*/RNA, Small Interfering*/RNA, Small Interfering*/administration & dosage ; RNA, Small Interfering*/RNA, Small Interfering*/RNA, Small Interfering*/pharmacokinetics ; Drug Development*/Drug Development*/Drug Development*/methods

  • Source: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Jul; Vol. 64 (7), pp. 799-809. Date of Electronic Publication: 2024 Mar 01.Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper.

Subjects: Drug Development*/Drug Development*/Drug Development*/methods ; Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/administration & dosage ; Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/adverse effects

  • Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2024 Sep; Vol. 116 (3), pp. 531-545. Date of Electronic Publication: 2024 May 16.Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium:

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  • 1-10 of  6,756 results for ""Drug development""