Bioequivalence and Drug Product Assessment

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.

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A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis.

Case Medical Research ◽

10.31525/ct1-nct03924947 ◽

2019 ◽

Author(s):

Keyword(s):

Cystic Fibrosis ◽

Drug Product ◽

Pancreatic Insufficiency ◽

Exocrine Pancreatic Insufficiency

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Analytical Methods Practiced to Quantitation of Rifampicin: A Captious Survey

Current Pharmaceutical Analysis ◽

10.2174/1573412916999200704144231 ◽

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.

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