Pharmaceutical Company Strategies for Designing Nonclinical Safety Programs for Products of Biotechnology
- PDF / 764,648 Bytes
- 6 Pages / 504 x 720 pts Page_size
- 49 Downloads / 187 Views
OIN2-8615/W Copyright :C I000 Dnif Inforinatiiin Association Inc.
Printed in the USA. All right5 re\erved.
PHARMACEUTICAL COMPANY STRATEGIES FOR DESIGNING NONCLINICAL SAFETY PROGRAMS FOR PRODUCTS OF BIOTECHNOLOGY SUSANA.
GRIFFITHS,
PHD
Project Leader. K & D Strategies, Centre for Medicines Research International. Surrey, United Kingdom
Strutegies j b r designin!: noric~lirricalsujety evulicution progrums ,for phurmaceuticol products of biotechnology. the types of studies c~)ndrrcted.and the reasons ,for their inclusion were identjfied through 11 questionnoire-brrsed survey of37 phnniiuceutical and biotechnology c~omputries.The majorih. of respondents were ulreudy using Interrrational Conference on Harmonization (ICH) guidance, then uvuilable only in druji. when choosing which studies to include; a high propor~iorrnlso sought intermtion with regulators at mn errrl? stage of progrum design. The survey revenled thnt a vuriety of strrrtegies hm'e been ridopted by the industry, consistent btith the cme-by-cuse rrpprouch considered nece.c..saryfi)r these products. Not d l sujety evirlutrtion studirs hnve been cwrduc.ted u s ptrrt of'u .sc.ieritific strttrtegy, howevec some huve been ~tridertnkerisolely to meet perceiLwI regulirtor:v e.rpec~tutionsor specific products in rrtrinial models requests. Although overdl c..rperieric.e of testing bi(~tei~Iiiiol~i~~.v of diseuse. homologous systems. und trunsgenic. unimuls M'US limited, per.conriel~frornboth biotechtrology ond ptrirrincri~eutic~rrI iwnrponies were keen to incorporate such ulternntive studies in the future. Key Words: Riotechnology; Safety evaluation; Pharmaceuticals
INTRODUCTION HISTORICALLY. THERE HAS been a lack of consensus within the pharmaceutical and biotechnology industry concerning which studies to include in nonclinical safety evaluation programs for pharmaceutical products of biotechnology. There has also been uncertainty concerning regulatory requirements or
Presented at the I X A 34th Annual Meeting "Thinking Globally: Product Development, Registration. and Marketing in the New Millennium," June 7-1 l , 1998. Boston. Massachusetts. Reprint address: Dr. Susan A . Griftiths. CMR International. Woodmansterne Road. Carshalton. Surrey SM5 41)s UK.
expectations for the content of these programs because, by the very nature of these products. a case-by-case approach is necessary. In addition, usually the human form of the protein is being developed which may not be pharmacologically or biologically active in the animal species commonly used for toxicity testing. Even if the product is active in these species, immunogenicity may preclude its evaluation using toxicological studies generally considered appropriate for new chemical entities. A previous Centre for Medicines Research (CMR) International survey of major pharmaceutical and biotechnology companies ( 1 ) revealed that the identification of a pharmacologically-relevant animal model to
933
Downloaded from dij.sagepub.com at UCSF LIBRARY & CKM on March 18, 2015
934
Susan A. Griffith.7
test t
Data Loading...
