scholarly journals Drug Product: Manufacturer(s)

2020 ◽  
Author(s):  
Keyword(s):  
Drug Product ◽  
Product Manufacturer

scholarly journals IMPORTANCE OF DEFICIENCY RESPONSE IN PHARMACEUTICAL ENVIRONMENT FOR DRUG APPROVAL

2018 ◽  
Vol 2 (4) ◽  
pp. 14-18
Author(s):  
Swagat Tripathy ◽  
P. N. Murthy
Keyword(s):  
Technical Writing ◽  
Drug Product ◽  
Writing Skills ◽  
Drug Approval ◽  
Review Cycle ◽  
Product Manufacturer

This illustrates examples of series deficiencies, that’s how really company faces problem due to deficiency. It’s to convey the message if drug product manufacturer can visualize earlier all aspect of risks and manifest proactively, then there is always least chance to have the said deficiency received. However, even then if company also gets deficiency, company could have equipped with earlier data. So, what they need to do is to focus properly for addressing agency’s query by utilizing proper scientific and technical writing skills. How lack of visualization creates problem, how review cycle prolonged and how by dint of this issue approval got delayed has been clearly discussed in this case study. The reason of so many rounds of questions and review cycles become longer and finally approval got delayed is from the beginning itself agency was not satisfied or convinced with the justification given by said Company.

scholarly journals DMF FILING IN US, EUROPE AND CANADA

2018 ◽  
Vol 3 (4) ◽  
pp. 9-17
Author(s):  
Pooja Agarwal ◽  
J. K. Badjatya
Keyword(s):  
Drug Product ◽  
Drug Application ◽  
Reference Source ◽  
Specific Process ◽  
New Drug ◽  
Animal Use ◽  
Human Animal ◽  
New Drug Application ◽  
Investigational New Drug Application ◽  
Product Manufacturer

A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.

SISTEM INFORMASI PENJUALAN DENGAN MENERAPKAN METODE SALES FORCE AUTOMATION

2019 ◽  
Vol 20 (3) ◽  
pp. 214-223
Author(s):  
Vivi Sahfitri
Keyword(s):  
Information System ◽  
Customer Service ◽  
Sales Force ◽  
Sales Force Automation ◽  
Sales Process ◽  
Marketing Area ◽  
Consumer Dissatisfaction ◽  
Product Manufacturer ◽  
The Way

The sales process is the most important part of the product manufacturer or the company being ditributor. Conventional sales system by the way telephone or consumer come directly to know the available or not the product needed to make consumers should take the time to do that. Such conditions can also lead to consumer dissatisfaction especially if the desired item is unavailable. Dissatisfaction with customer service can affect the indication of declining sales turnover. For that, the company needs a website-based sales information system that can be accessed by consumers anytime and anywhere so that it can expand its marketing area, and can facilitate salespeople to conduct promotions to Community. This research produces the sales information system by implementing a sales Force Automation (SFA) method which is expected to maximize the sales and focus of services to customers.

MULTI - DIMENSIONAL ROLE OF A PHARMACIST IN HOSPITAL: A HEALTH CARE PROVIDER

2018 ◽  
pp. 5-7
Author(s):  
Singh S ◽  
Virmani T ◽  
Virmani R ◽  
Geeta . ◽  
Gupta J
Keyword(s):  
Health Care ◽  
Urban Areas ◽  
Health Care Services ◽  
Drug Product ◽  
Hospital Pharmacist ◽  
Therapeutic Monitoring ◽  
Direct Patient Care ◽  
Rural And Urban Areas ◽  
Rural And Urban

The objective of this study was to point out multi-dimensional role of a pharmacist with a special emphasis on the hospital pharmacist. Apharmacist is a person who is involved in designing, creating or manufacturing of a drug product, dispensing of a drug, managing and planning ofa pharmaceutical care. They are experts on the action and uses of drugs, including their chemistry, pharmacology and formulation. Theprofessional life of a hospital pharmacist might seem insignificant as compared to that of doctors, but actually they are highly trained healthprofessionals who plays important role in patient safety, patient compliance, therapeutic monitoring and even in direct patient care. With thepassage of time and advancements in health care services and pharmaceuticals, the role of a hospital pharmacist has become more diversified. Toa career, a hospital pharmacist must possess a diploma/degree in pharmacy from an accredited pharmacy college and must be registered with thestate pharmacy council of their respective region. In this study, we have assessed the behavior, communication skills, qualifications of thepharmacist, prescription handling ability and other factors to evaluate the diversified role of hospital pharmacist and their comparison withpharmacists practicing in rural and urban areas. Current surveys show that the pharmacists are not practicing as per the standard due to lack ofproper guidelines and watch over their practicing sense. The rules and guidelines prescribed by the Food and drug administration (FDA) andIndian pharmacopeia commission (IPC) were not followed by the pharmacist.

Analytical Methods Practiced to Quantitation of Rifampicin: A Captious Survey

2020 ◽  
Vol 16 ◽  
Author(s):  
Rajendra Muljibhai Kotadiya ◽  
Foram Narottambhai Patel
Keyword(s):  
Thin Layer ◽  
Thin Layer Chromatography ◽  
Analytical Methods ◽  
Bacterial Infections ◽  
High Performance ◽  
Drug Product ◽  
Extensive Literature ◽  
Legionnaires Disease ◽  
Instrumental Methods ◽  
Layer Chromatography

Background: Rifampicin (RIF), also known as rifampin, a bactericidal antibiotic having broad antibacterial activity against various gram-positive and gram-negative bacteria act by inhibiting DNA dependent RNA polymerase. RIF has been administered in different dosage forms like tablets, capsules, injections, oral suspension, powder etc. for the treatment of several types of bacterial infections, including tuberculosis, Mycobacterium avium complex, leprosy and Legionnaires’ disease. Introduction: To ensure the quality, efficacy, safety and effectiveness of RIF drug product, effective and reliable analytical methods are utmost important. To quantify RIF for quality control or pharmacokinetic purposes, alternative analytical methods have been developed along with the official compendial methods. Method: In this review paper, an extensive literature survey was done to gather information on various analytical instrumental methods used so far for RIF. Result: These methods were high-performance liquid chromatography (42%), hyphenated techniques (18%), spectroscopy (15%), high-performance thin-layer chromatography or thin-layer chromatography (7%) and miscellaneous (18%). Conclusion: All these methods were selective and specific for the RIF analysis.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

scholarly journals Management of a parenteral opioid shortage using ASHP guidelines

2021 ◽  
Vol 78 (5) ◽  
pp. 426-435
Author(s):  
Peter Vo ◽  
Daniel A Sylvia ◽  
Loay Milibari ◽  
John Ryan Stackhouse ◽  
Paul Szumita ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Drug Product ◽  
Health Record ◽  
Large Hospital ◽  
Hospital Administrators ◽  
Utilization Data ◽  
Electronic Health ◽  
Opioid Medications ◽  
American Society ◽  
The Impact

Abstract Purpose Management of an acute shortage of parenteral opioid products at a large hospital through prescribing interventions and other guideline-recommended actions is described. Summary In early 2018, many hospitals were faced with a shortage of parenteral opioids that was predicted to last an entire year. The American Society of Health-System Pharmacists (ASHP) has published guidelines on managing drug product shortages. This article describes the application of these guidelines to manage the parenteral opioid shortage and the impact on opioid dispensing that occurred in 2018. Our approach paralleled that recommended in the ASHP guidelines. Daily dispensing reports generated from automated dispensing cabinets and from the electronic health record were used to capture dispenses of opioid medications. Opioid prescribing and utilization data were converted to morphine milligram equivalents (MME) to allow clinical leaders and hospital administrators to quickly evaluate opioid inventories and consumption. Action steps included utilization of substitute opioid therapies and conversion of opioid patient-controlled analgesia (PCA) and opioid infusions to intravenous bolus dose administration. Parenteral opioid supplies were successfully rationed so that surgical and elective procedures were not canceled or delayed. During the shortage, opioid dispensing decreased in the inpatient care areas from approximately 2.0 million MME to 1.4 million MME and in the operating rooms from 0.56 MME to 0.29 million MME. The combination of electronic health record alerts, increased utilization of intravenous acetaminophen and liposomal bupivacaine, and pharmacist interventions resulted in a 67% decline in PCA use and a 65% decline in opioid infusions. Conclusion A multidisciplinary response is necessary for effective management of drug shortages through implementation of strategies and practices for notifying clinicians of shortages and identifying optimal alternative therapies.

Sign in / Sign up

Export Citation Format

Share Document