Alkoloids : Study Material


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Drug Storage as per IP

DRUGS TO BE STORED
1.In a Frozen State:     Ceftazidime Inj

2° to 8° C:    
Antisera
BCG Vaccine
Carbenicillin Sodium Inj. [Biopence™ Carbelin™ Pyopen™]
Carboprost Tromethamine Inj. USP [Prostodin™]
Desferrioxamine Mesylate Inj. [Desferal™]
Dilzem™ Inj.
Dinoprostone Gel [Cerviprime 0.5mg.™Primiprost™]
Ergometrine Maleate Inj.
Gas-Gangrene Antitoxin (Oedematiens)
Gas-Gangrene Antitoxin (Perfringes)
Gas-Gangrene Antitoxin (Septicum)
Hepatitis B Virus Vaccine (H B Vac™ Enivac HB™ Engerrix B™
Heppacine-B™ Shanvac-B™)

Monographs: Dosage forms: General monographs: Tablets

Monographs: Dosage forms: General monographs: Tablets

Definition : Tablets are solid dosage forms containing one or more active ingredients. They are obtained by single or multiple compression (in certain cases they are moulded) and may be uncoated or coated. They are usually intended for oral administration, but preparations for alternative applications, such as implants, solution-tablets for injections, irrigations, or for external use, vaginal tablets, etc., are also available in this presentation. These preparations may require a special formulation, method of manufacture, or form of presentation, appropriate to their particular use. For this reason they may not comply with certain sections of this monograph.

The different categories of tablet that exist include soluble tablets, effervescent tablets, tablets for use in the mouth, and modified-release tablets. Unless otherwise specified in the individual monograph, tablets are normally circular in shape, and their surfaces are flat or convex. Tablets may have lines or break-marks, symbols, or other markings. They should be sufficiently hard to withstand handling, including packaging, storage, and transportation, without crumbling or breaking.

Now check genuineness of pharma products through SMS

US-based Sproxil on Tuesday announced the launch of its operations in India and unveiled a product to check the drug counterfeit market.
Mobile Product Authentication (MPA) enables consumers to verify the authenticity of a pharmaceutical product by sending the unique code on the drug as a free text message to the manufacturers in real time, Sproxil CEO Ashifi Gogo told reporters.

FDA Regulatory Affairs - A guide for prescription drugs, medical devices, and biologics

This book is a roadmap to the U.S. Food and Drug Administration and drug, biologic, and medical device development. It is written in plain English, with an emphasis on easy access to understanding how this agency operates with respect to the practical aspects of U.S. product approval. It is meant to be a concise reference that offers current, real-time information. It has been written as a handy reference for use by students, staff, and professionals at corporations, organizations, and schools and colleges across the United States in need of a simple, concise text from which to learn and teach. The topics in FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual reading of the Laws of the United States of America or the regulations of the U.S. Food and Drug Administration, it’s agencies or any body that regulates the development or approval of drugs, biologics, and medical devices in the United States.


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