Approved Drug Product Manufactured Under Contract

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

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.

Flexibility in Drug Product Development: A Perspective

2021 ◽  
Author(s):  
Yash Kapoor ◽  
Robert F. Meyer ◽  
Heidi M. Ferguson ◽  
Daniel Skomski ◽  
Pierre Daublain ◽  
...  
Keyword(s):  
Product Development ◽  
Drug Product

scholarly journals Current hurdles to the translation of nanomedicines from bench to the clinic

2021 ◽  
Author(s):  
Snežana Đorđević ◽  
María Medel Gonzalez ◽  
Inmaculada Conejos-Sánchez ◽  
Barbara Carreira ◽  
Sabina Pozzi ◽  
...  
Keyword(s):  
Drug Product ◽  
Early Stage ◽  
Regulatory Agencies ◽  
Important Process ◽  
Close Collaboration ◽  
Critical Quality Attributes ◽  
Research Areas ◽  
Physical Chemical ◽  
Clinical Models ◽  
Further Development

AbstractThe field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract

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