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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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A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation.

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

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

• Source: AAPS PharmSciTech [AAPS PharmSciTech] 2024 Aug 21; Vol. 25 (7), pp. 193. Date of Electronic Publication: 2024 Aug 21.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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Development of in vitro biopharmaceutics tools for predicting the bioavailability of subcutaneously injected monoclonal antibodies and oligonucleotides.

• Authors : Somby K; King's College London, Institute of Pharmaceutical Science, London, England.; Novartis Pharma AG, Basel, Switzerland.

Subjects: Biological Availability* ; Antibodies, Monoclonal*/Antibodies, Monoclonal*/Antibodies, Monoclonal*/administration & dosage ; Antibodies, Monoclonal*/Antibodies, Monoclonal*/Antibodies, Monoclonal*/pharmacokinetics

• Source: Expert opinion on drug delivery [Expert Opin Drug Deliv] 2024 Sep; Vol. 21 (9), pp. 1307-1310. Date of Electronic Publication: 2024 Sep 21.Publisher: Informa Healthcare Country of Publication: England NLM ID: 101228421 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Lack of Effect of Antioxidants on Biopharmaceutics Classification System (BCS) Class III Drug Permeability.

• Authors : Chiang Yu Y; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, 21201, USA.; Lu D

Subjects: Antioxidants*/Antioxidants*/Antioxidants*/pharmacology ; Antioxidants*/Antioxidants*/Antioxidants*/pharmacokinetics ; Permeability*

• Source: Journal of pharmaceutical sciences [J Pharm Sci] 2024 Aug; Vol. 113 (8), pp. 2215-2222. Date of Electronic Publication: 2024 Mar 12.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Justification of widened dissolution specifications of an extended-release product using physiologically based biopharmaceutics modeling.

• Authors : Bhattiprolu AK; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India.; Kollipara S

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Delayed-Action Preparations* ; Therapeutic Equivalency*

• Source: Xenobiotica; the fate of foreign compounds in biological systems [Xenobiotica] 2024 Oct; Vol. 54 (10), pp. 781-795. Date of Electronic Publication: 2024 Oct 14.Publisher: Informa Healthcare Country of Publication: England NLM ID: 1306665 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

• Authors : Pepin X; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.; Arora S

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Models, Biological*; Humans

• Source: Molecular pharmaceutics [Mol Pharm] 2024 Aug 05; Vol. 21 (8), pp. 3697-3731. Date of Electronic Publication: 2024 Jun 30.Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet

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Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.

• Authors : Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.; Arora S

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Drug Industry*/Drug Industry*/Drug Industry*/methods; Humans

• Source: Molecular pharmaceutics [Mol Pharm] 2024 May 06; Vol. 21 (5), pp. 2065-2080. Date of Electronic Publication: 2024 Apr 10.Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet

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Drug solubility in biorelevant media in the context of an inhalation-based biopharmaceutics classification system (iBCS).

• Authors : Floroiu A; Department of Pharmacy, Saarland University, 66123 Saarbrücken, Germany; Eurofins PHAST Development GmbH & Co. KG, 78467 Konstanz, Germany. Electronic address: .

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

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

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Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives.

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

Subjects: Biopharmaceutics* ; Drugs, Generic*; Therapeutic Equivalency

• Source: Journal of pharmaceutical sciences [J Pharm Sci] 2024 Feb; Vol. 113 (2), pp. 345-358. Date of Electronic Publication: 2023 Dec 01.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Adult and pediatric physiologically-based biopharmaceutics modeling to explain lamotrigine immediate release absorption process.

• Authors : Caleffi-Marchesini ER; Pharmacokinetics and Biopharmaceutics Laboratory, State University of Maringá, Maringá, PR, Brazil.; Herling AA

Subjects: Biopharmaceutics* ; Intestinal Absorption*/Intestinal Absorption*/Intestinal Absorption*/physiology; Adult

• Source: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Feb; Vol. 13 (2), pp. 208-221. Date of Electronic Publication: 2023 Nov 14.Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Using the refined Developability Classification System (rDCS) to guide the design of oral formulations.

• Authors : Beran K; Fraunhofer Institute for Translational Medicine and Pharmacology, Frankfurt am Main, Germany; Janssen Pharmaceutica NV, Pharmaceutical & Material Sciences, Beerse, Belgium.

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods; Administration, Oral ; Humans

• Source: Journal of pharmaceutical sciences [J Pharm Sci] 2024 Dec; Vol. 113 (12), pp. 3497-3517. Date of Electronic Publication: 2024 Oct 05.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Neural Network Models for Predicting Solubility and Metabolism Class of Drugs in the Biopharmaceutics Drug Disposition Classification System (BDDCS).

• Authors : Ashrafi A; Faculty of Electrical and Computer Engineering, University of Tabriz, Tabriz, Iran.; Teimouri K

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Neural Networks, Computer*; Solubility

• Source: European journal of drug metabolism and pharmacokinetics [Eur J Drug Metab Pharmacokinet] 2024 Jan; Vol. 49 (1), pp. 1-6. Date of Electronic Publication: 2023 Oct 21.Publisher: Springer France Country of Publication: France NLM ID: 7608491 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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iBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products.

• Authors : Hastedt JE; JDP Pharma Consulting, San Carlos, California 94070, United States.; Bäckman P

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Nebulizers and Vaporizers*; Solubility

• Source: Molecular pharmaceutics [Mol Pharm] 2024 Jan 01; Vol. 21 (1), pp. 164-172. Date of Electronic Publication: 2023 Dec 07.Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet

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Approaches to Account for Colon Absorption in Physiologically Based Biopharmaceutics Modeling of Extended-Release Drug Products.

• Authors : Jadhav H; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca Gothenburg, S-431 83 Mölndal, Sweden.; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, ON2 Herestraat 49, 3000 Leuven, Belgium.

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Intestinal Absorption*/Intestinal Absorption*/Intestinal Absorption*/physiology; Humans

• Source: Molecular pharmaceutics [Mol Pharm] 2023 Dec 04; Vol. 20 (12), pp. 6272-6288. Date of Electronic Publication: 2023 Oct 30.Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet

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Retrospective analysis of the biopharmaceutics characteristics of solid oral Modified-Release drug products in approved US FDA NDAs designated as Extended-Release or Delayed-Release formulations.

• Authors : Ahmed N; U.S. Food and Drug Administration (FDA), United States. Electronic address: .; Ly H

Subjects: Biopharmaceutics* ; Polymers*; United States

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

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[Reform and exploration of biopharmaceutics blended teaching in the context of "first-class undergraduate education"].

• Authors : Cai W; School of Life Sciences, Hubei University, Wuhan 430062, Hubei, China.; Lei J

Subjects: Biopharmaceutics* ; Curriculum*; Humans

• Source: Sheng wu gong cheng xue bao = Chinese journal of biotechnology [Sheng Wu Gong Cheng Xue Bao] 2023 Dec 25; Vol. 39 (12), pp. 5014-5023.Publisher: Ke xue chu ban she Country of Publication: China NLM ID: 9426463 Publication Model: Print Cited Medium: Internet ISSN: 1872-2075

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Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space.

• Authors : Miranda Dos Santos E; Department of Pharmaceutical Sciences, Institute of Environmental, Chemical and Pharmaceutical Sciences, Universidade Federal de São Paulo, UNIFESP, Rua São Nicolau, 210, Centro, Diadema, 09913-030, SP, Brazil.; Ferraz HG

Subjects: Biopharmaceutics* ; Models, Biological*; Therapeutic Equivalency

• Source: Journal of pharmaceutical sciences [J Pharm Sci] 2023 Dec; Vol. 112 (12), pp. 3131-3140. Date of Electronic Publication: 2023 Jul 19.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Revamping Biopharmaceutics-Pharmacokinetics with Scientific and Regulatory Implications for Oral Drug Absorption.

• Authors : Alimpertis N; Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.; PharmaInformatics Unit, ATHENA Research Center, Athens, Greece.

Subjects: Biopharmaceutics* ; Models, Biological*; Therapeutic Equivalency

• Source: Pharmaceutical research [Pharm Res] 2023 Sep; Vol. 40 (9), pp. 2167-2175. Date of Electronic Publication: 2023 Aug 03.Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium:

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Biopharmaceutics : From Fundamentals to Industrial Practice

• Authors : Hannah Batchelor

Subjects: Biopharmaceutics--methods; Drug DesignMEDICAL / Pharmacology

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SubQ-Sim: A Subcutaneous Physiologically Based Biopharmaceutics Model. Part 1: The Injection and System Parameters.

• Authors : Pepin XJH; Regulatory Affairs, Simulations Plus, Lancaster, CA, USA.; Grant I

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Diabetes Mellitus, Type 2*; Humans

• Source: Pharmaceutical research [Pharm Res] 2023 Sep; Vol. 40 (9), pp. 2195-2214. Date of Electronic Publication: 2023 Aug 27.Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium:

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Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.

• Authors : Ahmed T; Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd, Bachupally, Medchal Malkajgiri District, Hyderabad-500 090, Telangana, Hyderabad, India. .; Kollipara S

Subjects: Drugs, Generic*/Drugs, Generic*/Drugs, Generic*/adverse effects ; Drugs, Generic*/Drugs, Generic*/Drugs, Generic*/pharmacokinetics ; Therapeutic Equivalency*

• Source: The AAPS journal [AAPS J] 2023 Jul 27; Vol. 25 (5), pp. 77. Date of Electronic Publication: 2023 Jul 27.Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited

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Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS)-Based Biowaivers: A workshop Summary Report.

• Authors : Mehta M; US Food & Drug Administration, Silver Spring, MD, USA. Electronic address: .; Polli JE

Subjects: Biopharmaceutics*/Biopharmaceutics*/Biopharmaceutics*/methods ; Research Report*; Pharmaceutical Preparations

• Source: Journal of pharmaceutical sciences [J Pharm Sci] 2023 Jul; Vol. 112 (7), pp. 1749-1762. Date of Electronic Publication: 2023 May 03.Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Physiologically based biopharmaceutics modeling of regional and colon absorption in humans.

• Authors : Tannergren C; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden. Electronic address: .; Jadhav H

Subjects: Biopharmaceutics* ; Intestinal Absorption*/Intestinal Absorption*/Intestinal Absorption*/physiology; Humans

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

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Combined Liquid-State and Solid-State Nuclear Magnetic Resonance at Natural Abundance for Comparative Higher Order Structure Assessment in the Formulated-State of Biphasic Biopharmaceutics.

• Authors : Pujahari SR; Department of Biosciences and Bioengineering, IIT Bombay, Powai, Mumbai 400076, India.; Mali PS

Subjects: Biopharmaceutics* ; Proteins*/Proteins*/Proteins*/chemistry; Magnetic Resonance Spectroscopy/Magnetic Resonance Spectroscopy/Magnetic Resonance Spectroscopy/methods

• Source: Analytical chemistry [Anal Chem] 2023 Jun 06; Vol. 95 (22), pp. 8469-8477. Date of Electronic Publication: 2023 May 08.Publisher: American Chemical Society Country of Publication: United States NLM ID: 0370536 Publication Model: Print-Electronic Cited Medium: Internet

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Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective.

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

Subjects: Biopharmaceutics* ; Models, Biological*; Solubility

• Source: AAPS PharmSciTech [AAPS PharmSciTech] 2023 Feb 09; Vol. 24 (2), pp. 59. Date of Electronic Publication: 2023 Feb 09.Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932

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