Q11 Development and Manufacture of Drug Substances

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), Step 3

Development and Manufacture of an Inactive Oil Emulsion Newcastle Disease Vaccine in Iran

Achieving Continuous Manufacturing: Technologies and Approaches for Synthesis, Workup, and Isolation of Drug Substance May 20-21, 2014 Continuous Manufacturing Symposium.

This whitepaper highlights current challenges and opportunities associated with continuous synthesis, workup, and crystallization of active pharmaceutical ingredients (drug substances). We describe the technologies and requirements at each stage and emphasize the different considerations for developing continuous processes compared with batch. In addition to the specific sequence of operations ...

Poly Drug Use - A Challenge for Drug Treatment

Poly-drug use refers to the use of two or more substances at the one time or repeatedly. It is common among both recreational and regular drug users across the world. Poly-drug use is a great contributor to the global number of deaths related to drug overdose. In this case, the likelihood of drug overdose and its pertaining complications in an individual is higher especially when benzodiazepine...

A Prototype Intelligent Hybrid System for Hard Gelatin Capsule Formulation Development

the pharmaceutical industry’s need to maintain its economic incentive to develop new drugs, have required that the industry increase speed to market and reduce the number of failures and overall cost of new drug development. This need has made it imperative for the industry to use efficient, systematic approaches to both drug discovery and formulation design. To accelerate drug discovery, scien...