Experience of an academic institute in importing a novel preclinical drug into India.

The article throws light on the process of importing a novel preclinical drug into India based on the real-life experience from one of our studies. A novel drug "X" acting through a new mechanism of action was hypothesized by us to function as a neuroprotectant. It was decided to import this novel drug from a university located in Brazil. An official collaboration pact was exchanged between both the sides. In accordance with the Indian Drug and Cosmetics Act 1940, unauthorized import of drug into India is not permitted. Hence, we decided to apply for the import license from Government of India. During the process of registration, we realized that the CDSCO SUGAM portal did not have facilities for the application from academic institute. We further faced challenges in different steps of import such as registration of the institute, individual drug application, fee transaction through the bank for Form 12, and customs duty clearance in the New Delhi airport. The process of import of drug for the purpose of testing by academic institutes has not been regularized by the CDSCO, and we suggest the apex organization to make separate provision for the academic institutes. This will encourage more academic institutes in India to opt for global collaborative works. This narration will further help them in following the same footsteps without facing significant hurdles. If more research on novel chemical entities is carried out in various academic institutes of India, it would not be far that we discover a blockbuster drug making the whole world turn toward us.

[Ideas and methods of fresh herb basic research based on constituent structure theory].

Application of fresh herbs is a kind of special forms of traditional Chinese medicine. In China, there is a long and rich experience in clinical application of fresh herbs. Many studies showed that the efficacy of fresh herbs was better than that of dried herbs, but the further study about the difference of their chemical composition, effective components and the overall material basis were few. In this paper, the ideas and methods to study on material basis of the fresh herbs by comparing the difference of the fresh and dry herbs in medicine chemical composition and pharmacological activity of effective components with modern advanced separation, analysis and screening technology under the "Constituent structure theory" were proposed. It was an effectual method for studying on the reasonable development of Chinese medicine and fresh herbs resources.

The IND application.

Translational biomedical research is often directed to the introduction of a new drug or biologic intended to treat unmet medical need in humans. This unit describes the timing and content of the investigational new drug (IND) application, the primary document required by the U.S. FDA for the initiation of clinical trials in humans with any new chemical entity (NCE) or biologic. The IND application contains all the information necessary for the FDA to make an assessment of the risks and benefits of the proposed clinical trials for the NCE/biologic, containing a detailed but succinct description of the biology, safety, toxicology, chemistry and manufacturing process, and the proposed clinical plan. This unit is geared for those with little or no experience with the IND process and is intended as a global introduction to this, the initial stage of the drug development process for drugs used in humans.

Designing a molecular delivery system within a preclinical timeframe.

An understanding of solid-state chemistry, including polymorphism, can reduce the time to filing an investigative new drug (IND) application. Obtaining a stable formulation for IND studies is crucial and must be the focus of much of the early solid-state chemistry research. Simple formulations such as a chemical substance in capsule (CIC)--the chemical substance can be crystalline or amorphous--are preferable for the IND trial and the solubility/dissolution rate has an important role in manufacturing IND clinical supplies. Two fast-to-IND flowcharts are presented here for exploratory IND and conventional IND. The utilization of quality by design and process analytical chemistry (PAT) concepts at an early stage will lay the foundation for the accelerated development of the medicines that are successful in the IND trials.

Definições, conceitos e aspectos operacionais utilizados em farmacovigilância / Definitions, concepts and operational aspects utilized in drug surveillance

O artigo expõe definições e conceitos utilizados na área de farmacovigilância, métodos de pesquisa para a identificação de reações adversas a medicamentos, notificação e organização de sistemas de farmacovigilância. De modo geral, as ações de farmacovigilância assumem dois aspectos diversos conforme o objetivo a ser atingido: (i) ações dos profissionais de saúde, que mantêm contato direto com o paciente e (ii) organização de sistemas de coleta, análise, processamento de informaçao e disseminação dos resultados, que incluem os sistemas nacionais de farmacovigilância e o Centro Colaborativo de Monitorização Internacional de Medicamentos da Organização Mundial da Saúde. Para se estabelecer a verdadeira...

Pharmaceutical registration and how to get a drug on the market.

In this article we describe how to get a drug onto the market and outline the product development stages. Drug development programmes and regulatory control processes are complex, so only a basic outline will be given.