Log in

Relevant bibliographies by topics / Biopharmaceutical Drug Development / Journal articles

To see the other types of publications on this topic, follow the link: Biopharmaceutical Drug Development.

Journal articles on the topic 'Biopharmaceutical Drug Development'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the top 50 journal articles for your research on the topic 'Biopharmaceutical Drug Development.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.

1

Todorovic, Zoran, and Dragana Protic. "Bioethical issues in the development of biopharmaceuticals." Filozofija i drustvo 23, no. 4 (2012): 49–56. http://dx.doi.org/10.2298/fid1204049t.

Full text

Abstract:

Development of biopharmaceuticals is a challenging issue in bioethics. Unlike conventional, small molecular weight drugs, biopharmaceuticals are proteins derived from DNA technology and hybrid techniques with complex three dimensional structures. Immunogenicity of biopharmaceuticals should always be tested in clinical settings due to low predictive value of preclinical animal models. However, non-human primates (NHP) and transgenic mice could be used to address certain aspects of immunogenicity. Substantial efforts have been made to reduce NHP use in biopharmaceutical drug development, e.g. st

APA, Harvard, Vancouver, ISO, and other styles

2

Lamborn, Kathleen R., and Karl E. Peace. "Biopharmaceutical Statistics for Drug Development." Journal of the American Statistical Association 84, no. 406 (1989): 629. http://dx.doi.org/10.2307/2289980.

Full text

APA, Harvard, Vancouver, ISO, and other styles

3

Hovgaard, Lars. "Biopharmaceutical Drug Design and Development." Journal of Controlled Release 66, no. 2-3 (2000): 323. http://dx.doi.org/10.1016/s0168-3659(99)00284-9.

Full text

APA, Harvard, Vancouver, ISO, and other styles

4

Legg, Lorna, and K. E. Peace. "Biopharmaceutical Statistics for Drug Development." Applied Statistics 39, no. 1 (1990): 137. http://dx.doi.org/10.2307/2347829.

Full text

APA, Harvard, Vancouver, ISO, and other styles

5

Jennings, Simon, and K. E. Peace. "Biopharmaceutical Statistics for Drug Development." Journal of the Royal Statistical Society. Series A (Statistics in Society) 156, no. 1 (1993): 136. http://dx.doi.org/10.2307/2982881.

Full text

APA, Harvard, Vancouver, ISO, and other styles

6

Metzler, Carl M. "Biopharmaceutical statistics for drug development." Journal of Pharmaceutical Sciences 77, no. 8 (1988): 733. http://dx.doi.org/10.1002/jps.2600770822.

Full text

APA, Harvard, Vancouver, ISO, and other styles

7

Cvijic, Sandra, Svetlana Ibric, and Jelena Parojcic. "Integrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application." Chemical Industry 74, no. 6 (2020): 389–97. http://dx.doi.org/10.2298/hemind210104002c.

Full text

Abstract:

The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships between drug product quality attributes (in vitro data) and its clinical performance (in vivo data). In the present paper, contemporary biopharmaceutics toolkit including in vivo predictive dissolution testing, Biopharmaceutics Classification System, physiologically based pharmacokinetic and biopharmaceutics modeling and simulation, in vitro-in vivo correlati

APA, Harvard, Vancouver, ISO, and other styles

8

Bandaliyeva, A., S. Muslumzade, A. Huseynova, and M. Aslanov. "THE EFFECT OF THE PHYSICAL STATE OF THE SUBSTANCE ON THE THERAPEUTİC EFFİCACY OF DRUGS." Scientific heritage, no. 157 (March 25, 2025): 74–76. https://doi.org/10.5281/zenodo.15085530.

Full text

Abstract:

In recent years, several directions of biopharmaceutical research have been identified in pharmacy: studying the role of pharmaceutical factors, absorption conditions, biotransformation, biological affinity and its determination methods, development of methods for identifying drugs in biological fluids, investigation of drug pharmacokinetics, and determination of clinical effects. One of the main objectives of biopharmaceutics is to study the physical state of substances, which plays a crucial role in the therapeutic significance of drugs. In the past, insufficient attention was given to the p

APA, Harvard, Vancouver, ISO, and other styles

9

Biopharmaceutical, Classification System dissolution permeability Gastrointestinal track ., and J. Bhor1 Rashid Azeez2 Vinod A. Bairagi3 Kalyani. "Review: Biopharmaceutical Classification System." International Journal in Pharmaceutical Sciences 2, no. 3 (2024): 350–66. https://doi.org/10.5281/zenodo.10810211.

Full text

Abstract:

Dr. Gordon Amidon developed the Biopharmaceutical Classification System (BCS) to classify pharmacological compounds based on their solubility in water and intestinal permeability. His work in this area earned him the Science Award from the International Pharmaceutical Federation (FIP) in August 2006. The BCS has since been used by the U.S. Food and Drug Administration to estimate the absorption of oral medications in the intestines. It has become an indispensable tool in regulatory decision-making for drug development, allowing for the evaluation of dissolution, solubility, and intestinal perm

APA, Harvard, Vancouver, ISO, and other styles

10

Moscicki, Richard A., and P. K. Tandon. "Drug-Development Challenges for Small Biopharmaceutical Companies." New England Journal of Medicine 376, no. 5 (2017): 469–74. http://dx.doi.org/10.1056/nejmra1510070.

Full text

APA, Harvard, Vancouver, ISO, and other styles

11

Decheng Huang, Mingxuan Yang, Xin Wen, Siwei Xia, and Bo Yuan. "AI-Driven drug discovery: Accelerating the development of novel therapeutics in biopharmaceuticals." International Medical Science Research Journal 4, no. 8 (2024): 882–99. http://dx.doi.org/10.51594/imsrj.v4i8.1458.

Full text

Abstract:

Artificial Intelligence (AI) has emerged as a transformative force in drug discovery, revolutionizing the biopharmaceutical industry's approach to developing novel therapeutics. This paper provides a comprehensive overview of AI-driven drug discovery, focusing on its applications in accelerating the development of innovative treatments. We examine the fundamental AI technologies employed in drug discovery, including machine learning algorithms, deep learning architectures, and natural language processing techniques. The paper analyzes the integration of AI across various stages of the drug dis

APA, Harvard, Vancouver, ISO, and other styles

12

Kim, YongChan, Erdal Atukeren, and YeonWoo Lee. "A New Digital Value Chain Model with PLC in Biopharmaceutical Industry: The Implication for Open Innovation." Journal of Open Innovation: Technology, Market, and Complexity 8, no. 2 (2022): 63. http://dx.doi.org/10.3390/joitmc8020063.

Full text

Abstract:

The advancement of technology in the biopharmaceutical industry has spearheaded the speed and scale of digitalization in various aspects. New drug development is becoming more complex, costly, and challenging. This paper examines how the pharmaceutical value chain model could integrate with the product-life-cycle perspective to better explain the drug development process changes and how the digital transformation could be implemented at each stage of the drug development process. We suggest a new framework to capture digital value creation in the biopharmaceutical industry by focusing on the s

APA, Harvard, Vancouver, ISO, and other styles

13

Uppal, Shivangi, and Navjeevan Dadwal. "Product and process development compliance in the Indian biopharmaceutical industry: Challenges and innovations." Environment Conservation Journal 25, no. 4 (2024): 1085–91. https://doi.org/10.36953/ecj.28462883.

Full text

Abstract:

This study explored product and process development in the Indian biopharmaceutical industries, crucial in developing, manufacturing, and distributing biopharmaceutical products. Quality by Design (QbD) is a fundamental approach guiding product development, integrating scientific principles, and risk management throughout the lifecycle of biopharmaceutical products. Compliance, desired by regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO), the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA), and the International Organizat

APA, Harvard, Vancouver, ISO, and other styles

14

Miyashige, Tetsuya. "Analysis of R&D efficiency of new biopharmaceuticals based on large-scale quantitative analysis and careful case analysis." Impact 2021, no. 2 (2021): 59–61. http://dx.doi.org/10.21820/23987073.2021.2.59.

Full text

Abstract:

Research on the R&D efficiency of new biopharmaceuticals is geared towards enhancing efficiencies, such as improving drug development technologies and therefore speeding up the discovery and development of new treatments. Organisation theory is one way of exploring R&D efficiency and involves studying the behaviour of organisations with a view to enhancing organisational efficiency. Professor Tetsuya Miyashige and his team at the National Institute of Technology, Toyama College, Japan, are using large-scale quantitative analysis and careful case analysis to analyse the R&D efficien

APA, Harvard, Vancouver, ISO, and other styles

15

Miyashige, Tetsuya. "Analysis of R&D efficiency of new biopharmaceuticals based on large-scale quantitative analysis and careful case analysis." Impact 2021, no. 5 (2021): 19–21. http://dx.doi.org/10.21820/23987073.2021.5.19.

Full text

Abstract:

Research on the R&D efficiency of new biopharmaceuticals is geared towards enhancing efficiencies, such as improving drug development technologies and therefore speeding up the discovery and development of new treatments. Organisation theory is one way of exploring R&D efficiency and involves studying the behaviour of organisations with a view to enhancing organisational efficiency. Professor Tetsuya Miyashige and his team at the National Institute of Technology, Toyama College, Japan, are using large-scale quantitative analysis and careful case analysis to analyse the R&D efficien

APA, Harvard, Vancouver, ISO, and other styles

16

Bhambure, Rahul, Kaushal Kumar, and Anurag S. Rathore. "High-throughput process development for biopharmaceutical drug substances." Trends in Biotechnology 29, no. 3 (2011): 127–35. http://dx.doi.org/10.1016/j.tibtech.2010.12.001.

Full text

APA, Harvard, Vancouver, ISO, and other styles

17

Keller, G.-A. "Cell Imaging in Drug Discovery and Development." Microscopy and Microanalysis 7, S2 (2001): 620–21. http://dx.doi.org/10.1017/s1431927600029172.

Full text

Abstract:

While morphological analysis at both the light and electron microscopical levels has been fully exploited in academic research, its potential in biopharmaceutical industry has only been fully appreciated in recent years. The biotechnology industry has been developing highly specialized therapeutic molecules, particularly proteins and peptides that are directed to specific molecular targets. The pace of the development of new therapeutic molecules is expected to increase dramatically in the close future, as the biopharmaceutical community will capitalize on the new targets identified by the Hum

APA, Harvard, Vancouver, ISO, and other styles

18

van Tongeren, Susan, Jane A. Fagerland, Michael W. Conner, et al. "The Role of the Toxicologic Pathologist in the Biopharmaceutical Industry." International Journal of Toxicology 30, no. 5 (2011): 568–82. http://dx.doi.org/10.1177/1091581811413304.

Full text

Abstract:

Toxicologic pathologists contribute significantly to the development of new biopharmaceuticals, yet there is often a lack of awareness of this specialized role. As the members of multidisciplinary teams, toxicologic pathologists participate in all aspects of the drug development process. This review is part of an initiative by the Society of Toxicologic Pathology to educate scientists about toxicologic pathology and to attract junior scientists, veterinary students, and veterinarians into the field. We describe the role of toxicologic pathologists in identifying candidate agents, elucidating b

APA, Harvard, Vancouver, ISO, and other styles

19

Huang, Decheng, Mingxuan Yang, Xin Wen, Siwei Xia, and Bo Yuan. "AI-Driven Drug Discovery: Accelerating the Development of Novel Therapeutics in Biopharmaceuticals." Journal of Knowledge Learning and Science Technology ISSN: 2959-6386 (online) 3, no. 3 (2024): 206–24. http://dx.doi.org/10.60087/jklst.vol3.n3.p.206-224.

Full text

Abstract:

Artificial Intelligence (AI) has emerged as a transformative force in drug discovery, revolutionizing the biopharmaceutical industry's approach to developing novel therapeutics. This paper provides a comprehensive overview of AI-driven drug discovery, focusing on its applications in accelerating the development of innovative treatments. We examine the fundamental AI technologies employed in drug discovery, including machine learning algorithms, deep learning architectures, and natural language processing techniques. The paper analyzes the integration of AI across various stages of the drug dis

APA, Harvard, Vancouver, ISO, and other styles

20

McElroy, Mary C., Chris Kirton, Dan Gliddon, and Ron K. Wolff. "Inhaled biopharmaceutical drug development: nonclinical considerations and case studies." Inhalation Toxicology 25, no. 4 (2013): 219–32. http://dx.doi.org/10.3109/08958378.2013.769037.

Full text

APA, Harvard, Vancouver, ISO, and other styles

21

Demina, N. B., and S. A. Skatkov. "Development strategies and biopharmaceutical aspects of drug delivery systems." Russian Journal of General Chemistry 83, no. 12 (2013): 2519–23. http://dx.doi.org/10.1134/s1070363213120505.

Full text

APA, Harvard, Vancouver, ISO, and other styles

22

Jung, Ha Neul, and Jin-Seok Choi. "Development and Evaluation of Febuxostat Solid Dispersion through Ternary System." Yakhak Hoeji 68, no. 2 (2024): 105–11. http://dx.doi.org/10.17480/psk.2024.68.2.105.

Full text

Abstract:

Febuxostat is classified as a biopharmaceutical with low solubility in aqueous solution and high intestinal permeability (Biopharmaceutics Classification System [BCS] Class II drug). The solubility of a drug has the characteristic of increasing as pH increases. This study aims to improve the dissolution of febuxostat with Neusilin® US2 and Gelucire®50/13 by a solvent evaporation method. The optimal formulation (solid dispersion, SD1) is developed as a solid dispersion of febuxostat : Gelucire®50/13 : US2®= 1:2:4 (w/w), with a final weight of 280 mg. The dissolution of SD1 in distilled water is

APA, Harvard, Vancouver, ISO, and other styles

23

Preety, Kumari* Arti Kori Shivanand Patil. "Enhancing Biopharmaceutical Attributes Of Nateglinide Through Floating Microsphere Delivery: Development And Evaluation." International Journal in Pharmaceutical Sciences 2, no. 7 (2024): 639–54. https://doi.org/10.5281/zenodo.12702695.

Full text

Abstract:

Gastroretentive dosage forms might be used as a controlled-release drug delivery system. Gastroretentive floating medicines extend the duration for a drug's presence in the stomach & allow for controlled dispensing of a range of drugs as their size is less than that in stomach juices. The aim of this study is to develop and evaluate floating microspheres that improve the patient's experience using nateglinide as a model drug for type-2 diabetes mellitus. Material & Method: By using ethyl cellulose and Eudragit S-100 as release-delaying polymers, float spheres were created by

APA, Harvard, Vancouver, ISO, and other styles

24

Vohra, Payaam, Priya Patil, and Sudrshan Mirghal. "Liquisolid Compacts: A Paradigm in Drug Delivery System." International Journal of Pharmaceutical Sciences and Nanotechnology(IJPSN) 17, no. 5 (2024): 7646–47. https://doi.org/10.37285/ijpsn.2024.17.5.11.

Full text

Abstract:

Liquisolid compacts (LSCs) are a fascinating drug delivery technology that offers numerous advantages, particularly for Biopharmaceutical Classification System (BCS) class 2 drugs. In essence, they convert liquid medications into free-flowing, compressible powder forms suitable for tablet production with improved drug release characteristics. Formulation of liquisolid compacts represents a valuable strategy for overcoming solubility challenges, ultimately contributing to the development of an effective and patient-friendly drug delivery system.

APA, Harvard, Vancouver, ISO, and other styles

25

Okuyama, Ryo. "Leveraging Corporate Assets and Talent to Attract Investors in Japan: A Country with an Innovation System Centered on Large Companies." Journal of Risk and Financial Management 17, no. 12 (2024): 539. http://dx.doi.org/10.3390/jrfm17120539.

Full text

Abstract:

Drug discovery and development require significant costs and time, making investment acquisition crucial. However, there are few biopharmaceutical startups with high valuations in Japan. Unlike other countries, entrepreneurship in Japan is relatively inactive, and startups have a minimal presence in the drug-discovery field. Instead, in Japan’s innovation system, research and development (R&D) has been led by large incumbent companies, which are believed to have a wealth of promising assets and talent. This study tested the hypothesis that biopharmaceutical startups leveraging these assets

APA, Harvard, Vancouver, ISO, and other styles

26

Zurdo, Jesús, Andreas Arnell, Olga Obrezanova, et al. "Early Implementation of QbD in Biopharmaceutical Development: A Practical Example." BioMed Research International 2015 (2015): 1–19. http://dx.doi.org/10.1155/2015/605427.

Full text

Abstract:

In drug development, the “onus” of the low R&D efficiency has been put traditionally onto the drug discovery process (i.e., finding the right target or “binding” functionality). Here, we show that manufacturing is not only a central component of product success, but also that, by integrating manufacturing and discovery activities in a “holistic” interpretation of QbD methodologies, we could expect to increase the efficiency of the drug discovery process as a whole. In this new context, early risk assessment, using developability methodologies and computational methods in particular, can as

APA, Harvard, Vancouver, ISO, and other styles

27

Radha, G. V., K. Trideva Sastri, Sadhana Burada, and Jampala Rajkumar. "A SYSTEMATIC REVIEW ON SELF-MICRO EMULSIFYING DRUG DELIVERY SYSTEMS: A POTENTIAL STRATEGY FOR DRUGS WITH POOR ORAL BIOAVAILABILITY." International Journal of Applied Pharmaceutics 11, no. 1 (2019): 23. http://dx.doi.org/10.22159/ijap.2019v11i1.29978.

Full text

Abstract:

Currently a marked interest in developing lipid-based formulations to deliver lipophilic compounds. Self-emulsifying system has emerged as a dynamic strategy for delivering poorly water-soluble compounds. These systems can embrace a wide variety of oils, surfactants, and co-solvents. An immediate fine emulsion is obtained on exposure to water/gastro-intestinal fluids. The principal interest is to develop a robust formula for biopharmaceutical challenging drug molecules. Starting with a brief classification system, this review signifies diverse mechanisms concerning lipid-based excipients besid

APA, Harvard, Vancouver, ISO, and other styles

28

Martin, Pauline L., and Gerhard F. Weinbauer. "Developmental Toxicity Testing of Biopharmaceuticals in Nonhuman Primates." International Journal of Toxicology 29, no. 6 (2010): 552–68. http://dx.doi.org/10.1177/1091581810378896.

Full text

Abstract:

Developmental toxicity studies for pharmaceutical safety testing are designed to evaluate potential adverse effects of drug treatment on pregnancy and on the developing embryo/fetus. Biopharmaceuticals present specific challenges for developmental toxicity testing because the pharmacology of these molecules, which are frequently human-specific proteins, is often restricted to humans and nonhuman primates (NHPs). For those species-restricted molecules, the only option for the evaluation of potential effects on development of the human biopharmaceutical is to use NHPs. This article reviews each

APA, Harvard, Vancouver, ISO, and other styles

29

Ku, M. Sherry. "Use of the Biopharmaceutical Classification System in Early Drug Development." AAPS Journal 10, no. 1 (2008): 208–12. http://dx.doi.org/10.1208/s12248-008-9020-0.

Full text

APA, Harvard, Vancouver, ISO, and other styles

30

Shorr, Rob. "Biopharmaceutical Drug Design and Development. Susanna Wu-Pong , Yongyut Rojanasakul." Quarterly Review of Biology 76, no. 1 (2001): 74. http://dx.doi.org/10.1086/393779.

Full text

APA, Harvard, Vancouver, ISO, and other styles

31

Rajapakse, Anuradha, Nigel John Titchener-Hooker, and Suzanne S. Farid. "Modelling of the biopharmaceutical drug development pathway and portfolio management." Computers & Chemical Engineering 29, no. 6 (2005): 1357–68. http://dx.doi.org/10.1016/j.compchemeng.2005.02.010.

Full text

APA, Harvard, Vancouver, ISO, and other styles

32

Welch, Anthony R., Rachelle Salomon, and Soulmaz Boroumand. "Biopharmaceutical Drug Development Pillars: Begin With the End in Mind." Clinical Pharmacology & Therapeutics 105, no. 1 (2018): 33–35. http://dx.doi.org/10.1002/cpt.1273.

Full text

APA, Harvard, Vancouver, ISO, and other styles

33

I. Razinkov, Vladimir, Michael J. Treuheit, and Gerald W. Becker. "Methods of High Throughput Biophysical Characterization in Biopharmaceutical Development." Current Drug Discovery Technologies 10, no. 1 (2013): 59–70. http://dx.doi.org/10.2174/157016313804998915.

Full text

APA, Harvard, Vancouver, ISO, and other styles

34

I. Razinkov, Vladimir, Michael J. Treuheit, and Gerald W. Becker. "Methods of High Throughput Biophysical Characterization in Biopharmaceutical Development." Current Drug Discovery Technologies 10, no. 1 (2013): 59–70. http://dx.doi.org/10.2174/1570163811310010008.

Full text

APA, Harvard, Vancouver, ISO, and other styles

35

Guan, Danyingzi, Bianfei Xuan, Chengguang Wang, et al. "Improving the Physicochemical and Biopharmaceutical Properties of Active Pharmaceutical Ingredients Derived from Traditional Chinese Medicine through Cocrystal Engineering." Pharmaceutics 13, no. 12 (2021): 2160. http://dx.doi.org/10.3390/pharmaceutics13122160.

Full text

Abstract:

Active pharmaceutical ingredients (APIs) extracted and isolated from traditional Chinese medicines (TCMs) are of interest for drug development due to their wide range of biological activities. However, the overwhelming majority of APIs in TCMs (T-APIs), including flavonoids, terpenoids, alkaloids and phenolic acids, are limited by their poor physicochemical and biopharmaceutical properties, such as solubility, dissolution performance, stability and tabletability for drug development. Cocrystallization of these T-APIs with coformers offers unique advantages to modulate physicochemical propertie

APA, Harvard, Vancouver, ISO, and other styles

36

Ainslie, Garrett R., Myrtle Davis, Lorna Ewart, et al. "Microphysiological lung models to evaluate the safety of new pharmaceutical modalities: a biopharmaceutical perspective." Lab on a Chip 19, no. 19 (2019): 3152–61. http://dx.doi.org/10.1039/c9lc00492k.

Full text

Abstract:

Drug developers seek specific advancements in the development and qualification of microphysiological lung models for the evaluation of drug safety; here these essential elements are discussed from the perspective of the biopharmaceutical industry.

APA, Harvard, Vancouver, ISO, and other styles

37

Shaik, Abdul Naveed, and Ansar Ali Khan. "Physiologically based pharmacokinetic (PBPK) modeling and simulation in drug discovery and development." ADMET and DMPK 7, no. 1 (2019): 1–3. http://dx.doi.org/10.5599/admet.667.

Full text

Abstract:

Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic or physiology based mathematical modeling technique which integrates the knowledge from both drug-based properties including physiochemical and biopharmaceutical properties and system based or physiological properties to generate a model for predicting the absorption, distribution, metabolism and excretion (ADME) properties of a drug as well as pharmacokinetic behavior of a drug in preclinical species and humans.

APA, Harvard, Vancouver, ISO, and other styles

38

Caira, Mino R. "Cyclodextrin Inclusion of Medicinal Compounds for Enhancement of their Physicochemical and Biopharmaceutical Properties." Current Topics in Medicinal Chemistry 19, no. 25 (2019): 2357–70. http://dx.doi.org/10.2174/1568026619666191018101524.

Full text

Abstract:

Owing to their wide structural diversity and unique complexing properties, cyclodextrins (CDs) find manifold applications in drug discovery and development. The focus of this mini-review is on their uses as ‘enabling excipients’ both in the context of early drug discovery and in subsequent optimisation of drug performance. Features highlighted here include descriptions of the structures of CDs, synthetic derivatisation to fine-tune their properties, the nature of inclusion complexation of drugs within the CD cavity, methodology for the study of free and complexed hosts in the solid state and i

APA, Harvard, Vancouver, ISO, and other styles

39

Bansal, Anshul, Vikesh Kumar Shukla, and Shikha Chauhan. "A comprehensive study of Regulatory compliance for Biosimilars in US, EU and India." International Journal of Drug Regulatory Affairs 7, no. 2 (2019): 17–34. http://dx.doi.org/10.22270/ijdra.v7i2.313.

Full text

Abstract:

The biopharmaceutical industry has gained significant interest in the last decade as the numbers of blockbuster biologic products are losing their patent rights. The regulatory authority is also providing marketing approval for Biosimilar products. Biological medicines are biotechnology developed drugs having large molecule which is complex in nature and are very sensitive to manufacturing conditions and parameters. Even a minor change in manufacturing conditions alters the quality and safety aspects of end product owing to increased risk for immune response. Biopharmaceutical companies use in

APA, Harvard, Vancouver, ISO, and other styles

40

Qelliny, Milad Reda, Wesam W. Mustafa, Adel Al Fatease, Ali H. Alamri, Raid Alany, and Hamdy Abdelkader. "Biofunctional Excipients: Their Emerging Role in Overcoming the Inherent Poor Biopharmaceutical Characteristics of Drugs." Pharmaceutics 17, no. 5 (2025): 598. https://doi.org/10.3390/pharmaceutics17050598.

Full text

Abstract:

Background/Objectives: With advancements in biomaterial sciences, biofunctional excipients have emerged to focus on solving issues with the drugs’ inherent biopharmaceutical characteristics such as poor solubility, permeability, in vivo dissolution, and effective targeting. These advanced excipients significantly impact drug solubility, dissolution rates, absorption rates, permeation rates, penetration ability, targeting ability, and pharmacokinetic profiles. Methods: A literature review of recently published articles was prepared. Data were collected using scientific search engines. This revi

APA, Harvard, Vancouver, ISO, and other styles

41

Tsakiridou, Georgia, Antigoni Maria Papanastasiou, Panagiotis Efentakis, Maria Faidra Galini Angelerou, and Lida Kalantzi. "Challenges in the Investigation of Therapeutic Equivalence of Locally Applied/Locally Acting Drugs in the Gastrointestinal Tract: The Rifaximin Case." Pharmaceutics 17, no. 7 (2025): 839. https://doi.org/10.3390/pharmaceutics17070839.

Full text

Abstract:

Background: Locally acting gastrointestinal (GI) drugs present challenges for generic drug development because traditional bioequivalence measures, which rely on systemic drug levels, do not reflect local efficacy. This review examines regulatory guidelines for establishing therapeutic equivalence for such drugs, using rifaximin—a minimally absorbed, gut-localized antibiotic—as a case study. Methods: We reviewed bioequivalence guidelines from the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with the literature on rifaximin’s biopharmaceutical and

APA, Harvard, Vancouver, ISO, and other styles

42

Afshari-Mofrad, Masoud, and Ali Salim. "Iranian firms in biopharmaceutical value chain: where to go now?" Journal of Science and Technology Policy Management 11, no. 1 (2019): 49–63. http://dx.doi.org/10.1108/jstpm-12-2018-0123.

Full text

Abstract:

Purpose Motivated by the huge potential of biosimilars in the near future and rapid growth of Iranian biosimilar producing firms in recent two decades, this paper aims to explore the positioning of these firms in biopharmaceutical value chain and their path of technological capability building to extract policy-relevant advice. Design/methodology/approach As part of a two-year research project, an online questionnaire was designed and sent to biopharmaceutical experts in Iran between May and October 2016. Respondents came from biopharmaceutical firms. Also, 12 semi-structured interviews were c

APA, Harvard, Vancouver, ISO, and other styles

43

Bolje, Aljoša, and Stanislav Gobec. "Analytical Techniques for Structural Characterization of Proteins in Solid Pharmaceutical Forms: An Overview." Pharmaceutics 13, no. 4 (2021): 534. http://dx.doi.org/10.3390/pharmaceutics13040534.

Full text

Abstract:

Therapeutic proteins as biopharmaceuticals have emerged as a very important class of drugs for the treatment of many diseases. However, they are less stable compared to conventional pharmaceuticals. Their long-term stability in solid forms, which is critical for product performance, depends heavily on the retention of the native protein structure during the lyophilization (freeze-drying) process and, thereafter, in the solid state. Indeed, the biological function of proteins is directly related to the tertiary and secondary structure. Besides physical stability and biological activity, conform

APA, Harvard, Vancouver, ISO, and other styles

44

SHARMA, RAJESH, and ASHWANI MISHRA. "DEVELOPMENT AND CHARACTERIZATION OF GASTRO RETENTIVE TABLETS OF CLARITHROMYCIN FOR ANTIULCER EFFECT." Current Research in Pharmaceutical Sciences 12, no. 1 (2022): 40–45. http://dx.doi.org/10.24092/crps.2022.120106.

Full text

Abstract:

Gastroretentive floating drug delivery system (GFDDS) is used to prolong the gastric residence time after oral administration, at a particular site and controlled or modified the release of drug from the formulation.The purpose of the present study is to develop a gastro retentive floating drug delivery system to achieving controlled release so that is improves bioavailability of the formulation, Structure activity relationship based on Biopharmaceutical Properties of Clarithromycin indicates good biopharmaceutical Properties. Floating dosage form of Clarithromycin was designed for the treatme

APA, Harvard, Vancouver, ISO, and other styles

45

Golfar, Yeganeh, and Ali Shayanfar. "Prediction of Biopharmaceutical Drug Disposition Classification System (BDDCS) by Structural Parameters." Journal of Pharmacy & Pharmaceutical Sciences 22 (June 23, 2019): 247–69. http://dx.doi.org/10.18433/jpps30271.

Full text

Abstract:

Modeling of physicochemical and pharmacokinetic properties is important for the prediction and mechanism characterization in drug discovery and development. Biopharmaceutics Drug Disposition Classification System (BDDCS) is a four-class system based on solubility and metabolism. This system is employed to delineate the role of transporters in pharmacokinetics and their interaction with metabolizing enzymes. It further anticipates drug disposition and potential drug-drug interactions in the liver and intestine. According to BDDCS, drugs are classified into four groups in terms of the extent of

APA, Harvard, Vancouver, ISO, and other styles

46

Woo, Jonghak, Eungdo Kim, Tae-Eung Sung, Jongtaik Lee, Kwangsoo Shin, and Jeonghee Lee. "Developing an Improved Risk-Adjusted Net Present Value Technology Valuation Model for the Biopharmaceutical Industry." Journal of Open Innovation: Technology, Market, and Complexity 5, no. 3 (2019): 45. http://dx.doi.org/10.3390/joitmc5030045.

Full text

Abstract:

The financial valuation of a drug that is still under development is required for various purposes. The risk-adjusted net present value (r-NPV) method, which recently emerged in the biotech industry, uses the development attrition rate as a discount factor to reflect risk during each development phase. The r-NPV method was developed to overcome the disadvantages of the prevailing discounted cash flow and real options methods and considers drug type, as well as the stage of development in its approach. Using this method, the current study examines technology values in the biopharmaceutical indu

APA, Harvard, Vancouver, ISO, and other styles

47

Huang, Ziyi, Xinyu Li, Yakun Sun, et al. "Enhancing the Electrochemical Properties and Processing Techniques of Carbon Nanotubes for Bio pharmacological Applications: A Research Perspective." Highlights in Science, Engineering and Technology 58 (July 12, 2023): 297–303. http://dx.doi.org/10.54097/hset.v58i.10111.

Full text

Abstract:

Compared with other biopharmaceutical technologies, carbon nanotubes not only have unique structure, but also have strong electrochemical properties, which occupy an important position in the fields of chemistry, physics, biopharmaceutics and materials science, and have played an active role in promoting the development of biopharmaceutics and chemical industry in China. Carbon nanotubes (CNTs) are mainly used in the field of biopharmacology for the determination of small biological molecules and drug molecules, the determination of dopamine and thrombin, the determination of high concentratio

APA, Harvard, Vancouver, ISO, and other styles

48

Gillespie, James Judson, Gregory J. Privitera, and Joseph Gaspero. "Biopharmaceutical Entrepreneurship, Open Innovation, and the Knowledge Economy." Journal of Innovation Management 7, no. 2 (2019): 59–77. http://dx.doi.org/10.24840/2183-0606_007.002_0005.

Full text

Abstract:

This article focuses on the paradigm shift of the global biopharmaceutical sector’s utiliza- tion of open innovation models to optimize drug development. Leveraging four exemplars, this review highlights that traditionally propriety, non-collaborative biotechnology and pharmaceutical companies increasingly use principles, processes, and structures of open innovation to increase drug R&D effectiveness and efficiency. We discern three essential elements in the successful creation of open innovation partnerships: (i) culture, (ii) collaborative management skills, and (iii) strategic capabilit

APA, Harvard, Vancouver, ISO, and other styles

49

SK, Srivastava. "Development and Evaluation of Antifungal Efficacy of Ketoconazole Pharmacosome." Bioequivalence & Bioavailability International Journal 7, no. 2 (2023): 1–13. http://dx.doi.org/10.23880/beba-16000216.

Full text

Abstract:

Pharmacosomes are neutral colloidal, lipid vesicular drug delivery system having both negative & positive charge that enhance the bioavailability of drugs by enhacing their solubility both in aqueous as well as non-aqueous phase, additionally reduce gastrointestinal toxicity of drug. Ketoconazole is an imidazole derivative agent which is used both in the treatment of topical or systematic fungal infections with fungi static activity against dermatophytes, yeasts and other pathogenic fungi. Ketoconazole is Biopharmaceutical classification system (BCS) class II drugs that display pH dependen

APA, Harvard, Vancouver, ISO, and other styles

50

Dudhat, Kiran Rameshbhai. "Vital Medications in the World According to Preliminary BCS Classification: Prognostication of Solubility and Permeability." Journal of Clinical Trials and Regulations 4, no. 2 (2022): 1–19. http://dx.doi.org/10.46610/jctr.2022.v04i02.001.

Full text

Abstract:

The Biopharmaceutical Classification System (BCS) has been used as a predictive method to evaluate potential formulation impacts on oral medication bioavailability in humans. The BCS can assist in the prediction of in vivo product performance and the construction of mechanistic models that enable formulation assessments through the generation of scenarios when used in conjunction with in vitro dissolution testing. The applicability of current human BCS standards has not yet been examined in dogs, which restricts its application in canine medication development. The BCS has had a significant im

APA, Harvard, Vancouver, ISO, and other styles

We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!