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Current Catalog
First multi-year cumulation covers six years: 1965-70.
Bioactive Heterocycles VI
Heterocyclic chemistry is the biggest branch of chemistry covering two-thirds of the chemical literature and this book covers the hot topics of frontier research summarized by reputed scientists in the field.
Life Sciences Research to Product Development
The present volume, Life Sciences Research to Product Development: Regulatory Requirement Transforming, Volume 1, discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (US FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). Many researchers either abandon their work in the middle of the process or find it difficult to follow the rules. Therefore, it is not surprising that any biological researcher associated with drug development should have a thorough understanding of regulatory requirements. This volume incorporates all the requisite regulatory norms...
Herbal Drugs: Technology And Use
This book provides in-depth information on many Indian medical practices, including herbal treatments, crude drug preparation, and medicinal botany. This book provides an introduction to the fundamental concepts and practices of the Ayurvedic, Unani, Siddha, and Homeopathic medical systems. In addition to this, the book emphasizes the quality, safety, efficacy, effectiveness, and stability of herbal products, as well as guidelines for the standardization of herbal drugs, patenting issues, Good Manufacturing Practices (GMP), and regulatory concerns regarding herbal drugs and products. Alternative medicine, which includes herbal medicine, is becoming more popular. Herbal medicine is a signific...
The Assam Gazette
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WHO Expert Committee on Specifications for Pharmaceutical Preparations
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning systems (HVAC) ? illustrative part; Guidance on GMP for Validation including the general main text analytical procedure validation validation of computerized sy...
WHO Expert Committee on Specifications for Pharmaceutical Preparations
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.
Pharmacy Law and Ethics
The textbook of Pharmacy Ethics and Law has been written for students of diploma in pharmacy second year students keeping in mind specific requirements of the Pharmacy Council of India (PCI), Education Regulation - 2020. The book is covering the entire syllabus as per new PCI norms including practicals and MCQs. This book containing twenty one chapters including general principals of law, pharmacy act, drug and cosmetic act, medicinal and toilet preparation act, narcotic and psychotropic substance act, drug and magic remedies act, prevention cruelty to animals act, poison act, FSSAI, DPCO, code of ethics, medical termination pregnancy act, CDSCO, IPC, GRP, blood bank, biowaste management, bioethics, consumer protection act and medical devices.
WHO Expert Committee on Specifications for Pharmaceutical Preparations
The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia and received the annu...
Industrial Pharmacy -II
To ensure that the students can understand the concept and contents, the book has been written in a clear language. Each subject has been thoroughly explained. However, certain things that are significant and valuable are covered. This will make it easier for the students to connect their theoretical learning to the real-world needs of the pharmaceutical sector. The course would make all the students understand at least the following: · Know the process of pilot planting and the scale of pharmaceutical dosage forms · Understand the process of technology transfer from lab scale to commercial batch · Know different Laws and Acts that regulate the pharmaceutical industry · Understand the approval process and regulatory requirements for drug products Contents: 1. Pilot Plant Scale-up Techniques 2. Technology Development and Transfer 3. Regulatory Affairs & Regulatory Requirement for Drug Approval 4. Quality Management Systems 5. Indian Regulatory Requirements
