scholarly journals Evaluation of New Chemical Entities as Substrates of Liver Transporters in the Pharmaceutical Industry: Response to Regulatory Requirements and Future Steps

2017 ◽  
Vol 106 (9) ◽  
pp. 2251-2256
Author(s):  
Noriko Okudaira
Keyword(s):  
Pharmaceutical Industry ◽  
Regulatory Requirements ◽  
New Chemical Entities ◽  
Industry Response

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

2018 ◽  
Vol 3 (1) ◽  
pp. 75-87
Author(s):  
Dinesh Chandra Konuri ◽  
Mamillapalli S. ◽  
A. Elphine P. ◽  
Brahma S.R. Desu
Keyword(s):  
Pharmaceutical Industry ◽  
Comparative Study ◽  
Generic Drugs ◽  
Emerging Market ◽  
Generic Product ◽  
Regulatory Requirements ◽  
Registration Process ◽  
Regulated Markets ◽  
Device Agency ◽  
Japan And China

A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.

scholarly journals Basic Review: Solubility Enhancement by Using Various Approaches

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Baldha Krunal ◽  
Sanjay Savaliya ◽  
Payal N Vaja ◽  
Dr. Chetan H Borkhtaria
Keyword(s):  
Pharmaceutical Industry ◽  
Water Solubility ◽  
Development Stage ◽  
Solubility Enhancement ◽  
Therapeutic Action ◽  
Drug Solubility ◽  
Formulation Development ◽  
Bioavailability Enhancement ◽  
Screening Programs ◽  
New Chemical Entities

The solubility enhancement process of drugs plays a key role in the formulation development to achieve the bioavailability and therapeutic action of the drug at the target site. About 40% of the new chemical entities identified by pharmaceutical industry screening programs face numerous problems in the formulation and development stage because of poor water solubility and low bioavailability. Drug solubility and bioavailability enhancement are the important challenges in the field of formulation of pharmaceuticals.

scholarly journals Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance

2020 ◽  
Vol 11 ◽  
pp. 204209862090961
Author(s):  
Marina A. Malikova
Keyword(s):  
Pharmaceutical Industry ◽  
Health Professionals ◽  
Case Reports ◽  
Individual Case ◽  
Regulatory Requirements ◽  
Practical Applications ◽  
Safety Alert ◽  
Potential Safety ◽  
Post Marketing ◽  
Regulatory Decisions

Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safety signals by monitoring evolving trends. If there is a message identifying concern as potential safety signal, the transmission of individual case reports, as well as cumulative and aggregate reports will occur from pharmaceutical industry to the regulators; and based on their assessments of causality in relationship to the drug, the regulatory decisions will be made. Once regulators confirming a signal as a possible safety alert have made the decision, the decisions and the reasons must be communicated to health professionals, the pharmaceutical industry, and other parties involved (e.g. clinical trials participants, investigators, consumers and medical professionals at post-marketing stage, etc.).

scholarly journals The Pharmaceutical Industry in 2019. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Molecules ◽  
2020 ◽  
Vol 25 (3) ◽  
pp. 745 ◽  
Author(s):  
Beatriz G. de la Torre ◽  
Fernando Albericio
Keyword(s):  
Natural Products ◽  
Pharmaceutical Industry ◽  
Small Molecules ◽  
Chemical Structure ◽  
New Drugs ◽  
Antibody Drug Conjugates ◽  
Drug Conjugates ◽  
The Us ◽  
New Chemical Entities ◽  
Antibody Drug

During 2019, the US Food and Drug Administration (FDA) approved 48 new drugs (38 New Chemical Entities and 10 Biologics). Although this figure is slightly lower than that registered in 2018 (59 divided between 42 New Chemical Entities and 17 Biologics), a year that broke a record with respect to new drugs approved by this agency, it builds on the trend initiated in 2017, when 46 drugs were approved. Of note, three antibody drug conjugates, three peptides, and two oligonucleotides were approved in 2019. This report analyzes the 48 new drugs of the class of 2019 from a strictly chemical perspective. The classification, which was carried out on the basis of chemical structure, includes the following: Biologics (antibody drug conjugates, antibodies, and proteins); TIDES (peptide and oligonucleotides); drug combinations; natural products; and small molecules.

scholarly journals Risk Management in the Pharmaceutical Industry in Slovenian Companies

2017 ◽  
Vol 8 (1) ◽  
pp. 42-49 ◽  
Author(s):  
Nina Bucalo ◽  
Borut Jereb
Keyword(s):  
Risk Management ◽  
Supply Chain ◽  
Pharmaceutical Industry ◽  
Pharmaceutical Companies ◽  
Regulatory Requirements ◽  
The World ◽  
High Level ◽  
The Cost ◽  
Effective Assessment ◽  
World Supply

Abstract The pharmaceutical industry is one of the most competitive businesses in the world. Supply chain in this industry has been directed towards the production of large batches to avoid lack of supplies, and the achievement of regulatory requirements, at the cost of high level of inventory, higher costs and inventory write-off due to expiration or other reasons. In recent years this industry is facing major changes and challenges such as intense globalization processes, increased competition and innovations in technologies, which has broadened and deepened risks in supply chain. The paper reports the results of the study of the risk in distribution processes of Slovenian pharmaceutical companies, which was conducted among five companies and aims to draw attention to risks that arise in supply chain, to emphasize the importance of their management and to present a model for an effective assessment of risk in companies, developed at the Faculty of Logistics.

scholarly journals The Pharmaceutical Industry in 2018. An Analysis of FDA Drug Approvals from the Perspective of Molecules

Molecules ◽  
2019 ◽  
Vol 24 (4) ◽  
pp. 809 ◽  
Author(s):  
Beatriz G. de la Torre ◽  
Fernando Albericio
Keyword(s):  
Natural Products ◽  
Pharmaceutical Industry ◽  
Small Molecules ◽  
Drug Administration ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Previous Record ◽  
New Chemical Entities ◽  
Important Milestone

The Food and Drug Administration approved 59 new drugs (42 New Chemical Entities and 17 Biologics) during 2018. This number breaks the previous record of 53 approved by the same organization in 1996. The 17 new biologics approved in 2018 also represent an important milestone for this kind of drug and they clearly exceed the 12 approved in 2015 and 2017. Herein, the 59 new drugs of the class of 2018 are analyzed from a strictly chemical perspective. The classification has been carried out on the basis of the chemical structure and includes the following: Biologics (antibodies and enzymes); TIDES (peptides and oligonucleotides) and natural products; drug combinations; and small molecules.

scholarly journals Regulatory compliances in development of commercial scale process of Nanoparticles (Liposomes and Niosomes) in pharmaceutical industry : A review

2020 ◽  
Vol 11 (4) ◽  
pp. 7094-7101
Author(s):  
Daka Nagarjuna Reddy ◽  
Mahaveer Singh ◽  
Birendra Shrivastava ◽  
Ravi Kumar Konda
Keyword(s):  
Pharmaceutical Industry ◽  
Review Process ◽  
Indian Market ◽  
Regulatory Requirements ◽  
New Drug ◽  
Industry Study ◽  
Review Study ◽  
Critical Overview ◽  
Abbreviated New Drug Applications ◽  
Regulatory Landscape

The main objective of this review work was designed to explore the regulatory environments that govern the pharmaceutical industry. Main objective of regulatory department is to maintain the quality, safety and efficacy of the medical products it also ensures the standard of medicinal product for sales, importing and manufacturing. The biggest challenge faced by the pharma manufactures is Scaling up their production. Our review process focuses on regulatory requirements concerning Liposomes and Niosomes and their limitations in respect to industrial applicability. In detail explanation of what type of information should be submitted to FDA and EU in new drug applications (NDAs) or abbreviated new drug applications (ANDAs). By comparing these two developed regulatory markets we can build a strong regulation in Indian market on Liposomes and Niosomes. The review study deals with the sound knowledge about regulatory landscape that governs the pharmaceutical industry. Study describes in depth about liposomes and niosomes delivery systems and gives a critical overview of the current regulatory landscape surrounding commercialization efforts of higher-level complexity systems, the expected requirements and the hurdles faced by companies seeking to bring novel liposome and noisome based systems for clinical use to market.

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