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  • 1-10 ل  297 نتائج ل ""Equivalency""

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Subject : biopharmaceutics
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Academic Journal

Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets.

  • Authors : Jaiswal S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.; Ahmed T

Subjects: Biopharmaceutics* ; Models, Biological*; Administration, Oral

  • Source: Drug development and industrial pharmacy [Drug Dev Ind Pharm] 2021 May; Vol. 47 (5), pp. 778-789. Date of Electronic Publication: 2021 Jun 08.Publisher: Informa Healthcare Country of Publication: England NLM ID: 7802620 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Interchangeability Of Biological Drug Products-FDA Draft Guidance.

  • Authors : Endrenyi L; University of Toronto, Toronto, ON, Canada.; Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.

Subjects: Guidelines as Topic*; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*legislation & jurisprudence ; Biosimilar Pharmaceuticals/Biosimilar Pharmaceuticals/Biosimilar Pharmaceuticals/*therapeutic use

  • Source: Journal of biopharmaceutical statistics [J Biopharm Stat] 2019; Vol. 29 (6), pp. 1003-1010. Date of Electronic Publication: 2019 Apr 25.Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Establishment of an equivalence acceptance criterion for accelerated stability studies.

Subjects: Drug Stability* ; Drug Storage*/Drug Storage*/Drug Storage*/standards ; Drug Storage*/Drug Storage*/Drug Storage*/statistics & numerical data

  • Source: Journal of biopharmaceutical statistics [J Biopharm Stat] 2013; Vol. 23 (4), pp. 730-43.Publisher: Taylor & Francis Country of Publication: England NLM ID: 9200436 Publication Model: Print Cited Medium: Internet ISSN: 1520-5711

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Academic Journal

On the Biopharmaceutics Classification System Biowaiver of Ibuprofen.

  • Authors : García-Arieta A; Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products, Madrid, Spain.; Gordon J

Subjects: Anti-Inflammatory Agents, Non-Steroidal/Anti-Inflammatory Agents, Non-Steroidal/Anti-Inflammatory Agents, Non-Steroidal/*classification ; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*methods ; Cyclooxygenase Inhibitors/Cyclooxygenase Inhibitors/Cyclooxygenase Inhibitors/*classification

  • Source: Journal of pharmaceutical sciences [J Pharm Sci] 2015 Aug; Vol. 104 (8), pp. 2429-32. Date of Electronic Publication: 2015 Jun 02.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Keeping a critical eye on the science and the regulation of oral drug absorption: a review.

  • Authors : Macheras P; Laboratory of Biopharmaceutics-Pharmacokinetics, Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens 15771, Greece. ; Karalis V

Subjects: Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*methods ; Drug and Narcotic Control/Drug and Narcotic Control/Drug and Narcotic Control/*methods; Administration, Oral

  • Source: Journal of pharmaceutical sciences [J Pharm Sci] 2013 Sep; Vol. 102 (9), pp. 3018-36. Date of Electronic Publication: 2013 Apr 09.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies.

  • Authors : Cristofoletti R; Division of Bioequivalence, Brazilian Health Surveillance Agency (ANVISA), Brasília, Brazil. ; Chiann C

Subjects: Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*classification ; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*chemistry ; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/*classification

  • Source: Journal of pharmaceutical sciences [J Pharm Sci] 2013 Sep; Vol. 102 (9), pp. 3136-44. Date of Electronic Publication: 2013 Apr 11.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Biowaiver monographs for immediate release solid oral dosage forms: efavirenz.

  • Authors : Cristofoletti R; Brazilian Health Surveillance Agency (Anvisa), Division of Bioequivalence, Londrina State University, Londrina, Brazil.; Nair A

Subjects: Anti-HIV Agents/Anti-HIV Agents/Anti-HIV Agents/*chemistry ; Anti-HIV Agents/Anti-HIV Agents/Anti-HIV Agents/*pharmacokinetics ; Benzoxazines/Benzoxazines/Benzoxazines/*chemistry

  • Source: Journal of pharmaceutical sciences [J Pharm Sci] 2013 Feb; Vol. 102 (2), pp. 318-29. Date of Electronic Publication: 2012 Nov 22.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling.

  • Authors : Crison JR; Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey 08901, USA. ; Timmins P

Subjects: Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*classification ; Hypoglycemic Agents/Hypoglycemic Agents/Hypoglycemic Agents/*pharmacokinetics ; Metformin/Metformin/Metformin/*pharmacokinetics

  • Source: Journal of pharmaceutical sciences [J Pharm Sci] 2012 May; Vol. 101 (5), pp. 1773-82. Date of Electronic Publication: 2012 Feb 14.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Biosimilars: illustration of scientific issues in two examples.

  • Authors : Wenzel RG; Diamond Headache Clinic Inpatient Unit, St. Joseph Hospital, 2900 North Lake Shore Drive, Chicago, IL 60657, USA.

Subjects: Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*standards ; Botulinum Toxins, Type A/Botulinum Toxins, Type A/Botulinum Toxins, Type A/*chemistry ; Botulinum Toxins, Type A/Botulinum Toxins, Type A/Botulinum Toxins, Type A/*pharmacology

  • Source: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2008 Jul 15; Vol. 65 (14 Suppl 6), pp. Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Implications of biosimilars for the future.

  • Authors : Johnson PE; H. Lee Moffitt Cancer Center, 12902 Magnolia Dr., Tampa, FL 33612-9497, USA.

Subjects: Biological Products/Biological Products/Biological Products/*history ; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*history ; Biopharmaceutics/Biopharmaceutics/Biopharmaceutics/*trends

  • Source: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2008 Jul 15; Vol. 65 (14 Suppl 6), pp. Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN:

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  • 1-10 ل  297 نتائج ل ""Equivalency""