The Role of the Drug Discovery, Clinical, and Regulatory Affairs Teams in Turning a Potent Agent into a Registered Product

Prabu, S.; Rathinasabapathy, Thirumurugan; Suriyaprakash, T.N.K.

doi:10.1016/b978-0-12-409547-2.11400-3

Cited by 5 publications

(2 citation statements)

References 49 publications

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“…Additionally, the aseptically manufactured drug substances and products are specified with the microbiological quality. As those new drug substances or products should meet the specification as per the acceptance criteria (Lakshmana Prabu et al 2014a).…”

Section: Microbial Testing Methodsmentioning

confidence: 99%

Revolutionizing the Major Threat Challenges in Pharmaceutical Industries by Monitoring Heating, Ventilation and Air Conditioning Systems

Tamilselvan,

Umamaheswari,

Lakshmana Prabu

2023

ORUPRS

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The environmental as well as personal individuals are mainly influenced by the air ventilation. In pharmaceutical industry the efficacy of substances including raw materials, in-process ingredients, finished products and machineries in the pharmaceutical manufacturing industry is mainly influenced by the air ventilation quality in interior area of the industry. Heating, ventilation and airconditioning system plays a vital role in ensuring the quality pharmaceutical drug substances as well as drug products. It also protects the pharmaceutical products from contamination and cross contamination from various contaminants like dust or dirt particles and environmental other microorganisms. HVAC system design impacts the architectural design layout of the building as these sequentially have an influence on the room pressure, pressure cascades, pressure differentials, contamination and cross-contamination control. So, the design of the system must be considered carefully at the primary design period of the pharmaceutical industrial plant.It also controls a variety of operating functions which are involved in regulating the acceptance criteria, quality assurance, validation and qualification of the building facility, operational documents and the documentation for maintenance. These protocols are mainly followed and performed for new equipment’s, utilities, premises and systems, at periodic intermissions, as soon as major variations have been completed. This chapter provides insight into the superlative necessities of HVAC system on the environmental protection in pharmaceutical industries and also about the role of it in manufacturing of drug substances and products in the production unit of the industrial plant. In addition, it summarizes existing information about the validation, qualification, maintenance, risk assessment and also highlights about the automation of HVAC system in the pharmaceutical industries.

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Section: Microbial Testing Methodsmentioning

confidence: 99%

Revolutionizing the Major Threat Challenges in Pharmaceutical Industries by Monitoring Heating, Ventilation and Air Conditioning Systems

Tamilselvan,

Umamaheswari,

Lakshmana Prabu

2023

ORUPRS

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“…The information obtained provides an insight on the period of drug treatment to be given, potential targets of the toxicity, no observed adverse effect levels (NOAELs) as well as any reversibility of any observed adverse effect. This study could also be relevant in assessing the carcinogenic potential of a substance 100 .…”

Section: Preclinical Toxicology Studiesmentioning

confidence: 99%

Investigation of phenylpropanoid sucrose esters as antidiabetic compounds

Wong¹

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First of all, I would like to express my profound thanks to my supervisor, Assoc. Prof.Zaher Judeh, for his patience, guidance and encouragement. This work would not have been possible without his valuable insights, suggestions and support. Next, I would also like to express my grattitude to my co-supervisor, Asst. Prof. Yusuf Ali, as well as my mentor, Assoc. Prof. Raymond Lau, for their kind support and encouragement. I would like to show my heartfelt appreciation to Prof. Subbu Venkatraman and Prof. Liu Xuewei who have kindly allowed me to tap into the facilities in their laboratory. Not forgetting the guidance that Dr. Zhang Yi Ming and Dr. Kho Shu Hui have provided me with in biological cell work and NMR analysis respectively. I am also thankful to Dr. Khong Duc Thing, who has offered me numerous advice and guidance in the beginning of my research work. Without his help and support, I would not have been able to complete this journey. Not forgetting my direct senior, Dr. Ong Li Lin, who has been providing with useful insights and guiding me all along right from the start of the project. In addition, I am also grateful to my lab mates, Shuddhodana and Varsha and my friends from SCBE-William, Lim Yun, Rita, Felix and Kuan Rei for their encouraging support. I would also like to thank SCBE Professional Officer and Lab Technicians, Dr. Ong Teng Teng, Jessica and Chea Boon, for providing technical assistance. I am also grateful to School of Chemical and Biomedical Engineering NTU, which has provided me with the necessary research facilities and environment. Most importantly, I would like to express my appreciation to Interdisciplinary Graduate School (IGS) for offering the scholarship to me. Without their generosity, this journey would not have been made possible. I am also grateful to the administrative staff from IGS and IGS-HealthTech NTU for their assistance throughout the past years. This journey has been rather taxing and I am ever thankful to all my close friends-Shu Hui, Yun Hui, Hwee Ping, Regina and Timothy who have showered me with constant support and encouragement. Not forgetting my friends whom I have made over the two years of my stay in CresPion hall. Last but not least, I owe the deepest grattitude to my dearest familymy parents and sisters, for their unwavering support and encouragement.

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Drug Discovery

Prabu

2019

Advances in Medical Technologies and Clinical Practice

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Modern chemistry foundations were made in between the 18th and 19th centuries and have been extended in 20th century. R&D towards synthetic chemistry was introduced during the 1960s. Development of new molecular drugs from the herbal plants to synthetic chemistry is the fundamental scientific improvement. About 10-14 years are needed to develop a new molecule with an average cost of more than $800 million. Pharmaceutical industries spend the highest percentage of revenues, but the achievement of desired molecular entities into the market is not increasing proportionately. As a result, an approximate of 0.01% of new molecular entities are approved by the FDA. The highest failure rate is due to inadequate efficacy exhibited in Phase II of the drug discovery and development stage. Innovative technologies such as combinatorial chemistry, DNA sequencing, high-throughput screening, bioinformatics, computational drug design, and computer modeling are now utilized in the drug discovery. These technologies can accelerate the success rates in introducing new molecular entities into the market.

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The Role of the Drug Discovery, Clinical, and Regulatory Affairs Teams in Turning a Potent Agent into a Registered Product

Cited by 5 publications

References 49 publications

Revolutionizing the Major Threat Challenges in Pharmaceutical Industries by Monitoring Heating, Ventilation and Air Conditioning Systems

Revolutionizing the Major Threat Challenges in Pharmaceutical Industries by Monitoring Heating, Ventilation and Air Conditioning Systems

Investigation of phenylpropanoid sucrose esters as antidiabetic compounds

Drug Discovery

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