The Common Technical Document: the changing face of the New Drug Application

2003 ◽  
Vol 2 (1) ◽  
pp. 71-74 ◽  
Author(s):  
Justina Molzon
Keyword(s):  
Drug Application ◽  
Technical Document ◽  
New Drug ◽  
The Common ◽  
New Drug Application

The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology

2001 ◽  
Vol 35 (2) ◽  
pp. 117-130 ◽  
Author(s):  
D. Smith ◽  
P. Trennery ◽  
D. Farningham ◽  
J. Klapwijk
Keyword(s):  
Drug Application ◽  
Common Marmoset ◽  
Callithrix Jacchus ◽  
Clinical Toxicology ◽  
Rodent Species ◽  
Clinical Safety ◽  
Advantages And Disadvantages ◽  
New Drug ◽  
The Common ◽  
New Drug Application

Prior to controlled clinical trials in human volunteers or patients it is required that novel pharmaceuticals are evaluated for pre-clinical safety in a rodent and a non-rodent ('second') species. In most cases the rodent species used has been the rat and the second species has been the dog or macaque (usually cynomolgus or rhesus) monkey. However, there is an increasing trend within the United Kingdom (UK) pharmaceutical industry to use the common marmoset ( Callithrix jacchus) for pre-clinical toxicology programmes. This paper examines the practicality of using the common marmoset (henceforth referred to as 'the marmoset') in toxicological testing and reviews metabolic and pharmacodynamic similarities between this species and humans. It then discusses some of the advantages and disadvantages of the use of this species when compared with two other alternatives to the dog and macaque, namely the ferret and minipig. In particular, the marmoset has clear advantages over the macaque in terms of animal welfare and practicality. There is regulatory acceptance of this species for Investigational New Drug (IND), Clinical Trial Exemption (CTX), New Drug Application (NDA) and Marketing Authorization Application (MAA) registrations. Whilst the dog is likely to be maintained as the primary non-rodent species in toxicology, the marmoset has been, and will likely continue to be, adopted as an additional non-rodent species in pre-clinical toxicology programmes where appropriate.

Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for Sarcoma

2018 ◽  
Vol 52 (3) ◽  
pp. 334-338 ◽  
Author(s):  
Akihiro Hirakawa ◽  
Tadaaki Nishikawa ◽  
Kan Yonemori ◽  
Taro Shibata ◽  
Kenichi Nakamura ◽  
...  
Keyword(s):  
Drug Application ◽  
Phase 2 ◽  
Rare Cancers ◽  
New Drug ◽  
Phase 2 Trial ◽  
New Drug Application

scholarly journals FDA relations during drug development

2000 ◽  
Vol 2 (3) ◽  
pp. 213-217
Keyword(s):  
Drug Development ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
Legal Aspects ◽  
Development Programs ◽  
New Drug ◽  
Regulatory Affairs ◽  
New Drug Application ◽  
Drug Development Program

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.

scholarly journals COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

2018 ◽  
Vol 3 (3) ◽  
pp. 8-20
Author(s):  
Jimi Patel ◽  
Priti Mehta ◽  
Vaishali Kothari
Keyword(s):  
Development Strategy ◽  
Classification System ◽  
Drug Application ◽  
Biopharmaceutics Classification System ◽  
New Drug ◽  
Novel Approach ◽  
Permeability Study ◽  
New Drug Application ◽  
Biopharmaceutics Classification

To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.

scholarly journals INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION

2018 ◽  
Vol 2 (1) ◽  
pp. 29-31
Author(s):  
Rajkumar Gupta
Keyword(s):  
Generic Drugs ◽  
Drug Application ◽  
Data Integrity ◽  
Marketing Authorization ◽  
Electronic Submission ◽  
New Drug ◽  
Patent Rights ◽  
New Drug Application

ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respect to patent rights and BE evaluations. The incomplete applications are often refused to file and the accepted applications some time get disqualified due to technical deficiencies at the manufacturing site. Recently FDA has rejected many ANDA applications in ASEAN region on account of data integrity.

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