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Academic Journal

Anatomically-detailed segmented representative adult and pediatric nasal models for assessing regional drug delivery and bioequivalence with suspension nasal sprays.

  • Authors : Khadka P; Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA.; Hejazi M

Subjects: Nasal Sprays* ; Therapeutic Equivalency* ; Models, Anatomic*

  • Source: International journal of pharmaceutics [Int J Pharm] 2024 Dec 05; Vol. 666, pp. 124743. Date of Electronic Publication: 2024 Sep 27.Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7804127 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack.

  • Authors : Kollipara S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, 500090, Telangana, India. .; Prabhat PK

Subjects: Mesalamine*/Mesalamine*/Mesalamine*/pharmacokinetics ; Mesalamine*/Mesalamine*/Mesalamine*/administration & dosage ; Mesalamine*/Mesalamine*/Mesalamine*/chemistry

  • Source: AAPS PharmSciTech [AAPS PharmSciTech] 2024 Dec 02; Vol. 26 (1), pp. 1. Date of Electronic Publication: 2024 Dec 02.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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Academic Journal

A Phase I Clinical Trial to Evaluate the Bioequivalence of an Adalimumab Biosimilar Adalimumab-WIBP and Humira ® .

  • Authors : Hu S; Phase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, 430023, China.

Subjects: Adalimumab*/Adalimumab*/Adalimumab*/pharmacokinetics ; Adalimumab*/Adalimumab*/Adalimumab*/administration & dosage ; Adalimumab*/Adalimumab*/Adalimumab*/adverse effects

  • Source: Clinical drug investigation [Clin Drug Investig] 2024 Dec; Vol. 44 (12), pp. 951-960. Date of Electronic Publication: 2024 Nov 15.Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9504817 Publication Model: Print-Electronic Cited Medium: Internet

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Academic Journal

Machine learning driven bioequivalence risk assessment at an early stage of generic drug development.

  • Authors : Krajcar D; Lek Pharmaceuticals d.d., A Sandoz Company, Verovskova 57, 1526 Ljubljana, Slovenia; Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia. Electronic address: .

Subjects: Therapeutic Equivalency* ; Machine Learning* ; Drugs, Generic*/Drugs, Generic*/Drugs, Generic*/pharmacokinetics

  • Source: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2024 Dec; Vol. 205, pp. Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 9109778 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Bioequivalence and Pharmacokinetic Evaluation of Regorafenib Tablets in Healthy Chinese Volunteers.

  • Authors : Wang Z; Clinical Pharmacokinetics Laboratory, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.; Zhang Y

Subjects: Pyridines*/Pyridines*/Pyridines*/pharmacokinetics ; Pyridines*/Pyridines*/Pyridines*/administration & dosage ; Pyridines*/Pyridines*/Pyridines*/adverse effects

  • Source: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Dec; Vol. 13 (12), pp. 1317-1323. Date of Electronic Publication: 2024 Oct 23.Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward.

  • Authors : Chougule M; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090, Telangana, India.; Kollipara S

Subjects: Models, Biological* ; Therapeutic Equivalency* ; Computer Simulation*

  • Source: European journal of clinical pharmacology [Eur J Clin Pharmacol] 2024 Dec; Vol. 80 (12), pp. 1903-1922. Date of Electronic Publication: 2024 Oct 08.Publisher: Springer Country of Publication: Germany NLM ID: 1256165 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1041

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Academic Journal

Phase 1 Evaluation of the Bioequivalence and Drug-Drug Interaction Potential of a Novel Fixed-Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine.

  • Authors : Lim HS; Clinical Trials Center, Chungnam National University Hospital, Daejeon, Republic of Korea.; Department of Medical Science, Chungnam National University College of Medicine, Daejeon, Republic of Korea.

Subjects: Amlodipine*/Amlodipine*/Amlodipine*/pharmacokinetics ; Amlodipine*/Amlodipine*/Amlodipine*/administration & dosage ; Amlodipine*/Amlodipine*/Amlodipine*/adverse effects

  • Source: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Dec; Vol. 13 (12), pp. 1345-1354. Date of Electronic Publication: 2024 Sep 27.Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double-Blind, Parallel-Group, Single-Dose Trial in Healthy Subjects.

Subjects: Biosimilar Pharmaceuticals*/Biosimilar Pharmaceuticals*/Biosimilar Pharmaceuticals*/pharmacokinetics ; Biosimilar Pharmaceuticals*/Biosimilar Pharmaceuticals*/Biosimilar Pharmaceuticals*/administration & dosage ; Biosimilar Pharmaceuticals*/Biosimilar Pharmaceuticals*/Biosimilar Pharmaceuticals*/adverse effects

  • Source: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Dec; Vol. 13 (12), pp. 1308-1316. Date of Electronic Publication: 2024 Sep 19.Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

A Bioequivalence Trial of Lenvatinib Mesylate Capsules in Healthy Subjects Under Fasting and Postprandial Conditions.

  • Authors : Shao J; Nanjing Caremo Biomedical Co., Ltd., Nanjing, China.; Jiangsu Dongke Kangde Pharmaceutical Co., Ltd., Nanjing, China.

Subjects: Therapeutic Equivalency* ; Quinolines*/Quinolines*/Quinolines*/pharmacokinetics ; Quinolines*/Quinolines*/Quinolines*/administration & dosage

  • Source: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Dec; Vol. 13 (12), pp. 1324-1330. Date of Electronic Publication: 2024 Sep 10.Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers.

  • Authors : Hu S; Phase I Clinical Trial Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology; Hubei Clinical Research Center for Infectious Diseases

Subjects: Therapeutic Equivalency* ; Cross-Over Studies* ; Healthy Volunteers*

  • Source: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Dec; Vol. 13 (12), pp. 1339-1344. Date of Electronic Publication: 2024 Sep 05.Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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  • 1-10 of  12,763 results for ""Therapeutic Equivalency""