S9 Q&A Step 5 Nonclinical evaluation for anticancer ...

Q12 Step 2b Technical and regulatory …

ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36

  Product, Management, Lifecycle, Product lifecycle management

Guideline on good pharmacovigilance practices …

9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25

  Good, Practices

Guideline on good pharmacovigilance practices …

Guideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification

  Good, Practices, Clinical, Good clinical practice

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November

  Guidelines, Good, Practices, Clinical, Good clinical practice e6

Guideline on good pharmacovigilance practices …

harmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product

  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance

European Medicines Agency

© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline

  Guidelines, European, Agency, Medicine, Harmonised, European medicines agency, Ich harmonised

products1/traditional herbal medicinal products

There is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already

  Product, Medicinal, Traditional, Herbal, Products1 traditional herbal medicinal products, Products1

Q7 Q&A - good manufacturing practice for active ...

ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37

  Good, Practices, Pharmaceutical, Manufacturing, Active, Ingredients, Good manufacturing practice for active, Good manufacturing practice for active pharmaceutical ingredients

HALDOL - Food and Drug Administration

The need for continued treatment should be reassessed periodically. ... Carcinogenicity studies using oral haloperidol were conducted in Wistar rats (dosed at up to 5 mg/kg daily for 24 months) and in Albino Swiss mice (dosed at up to 5 mg/kg daily for 18 months). In the rat study survival was less than optimal in all

  Administration, Drug, Food and drug administration, Food, Studies, Needs, Carcinogenicity, Carcinogenicity studies, The eden, Haldol

S 3 A Toxicokinetics: A Guidance for Assessing Systemic ...

Toxicity studies which may be usefully supported by toxicokinetic information include single and repeated-dose toxicity studies, reproductive, genotoxicity and carcinogenicity studies. Toxicokinetic information may also be of value in assessing the implications of a proposed change in the clinical route of administration. 3.

  Studies, Carcinogenicity, Carcinogenicity studies

Safety Data Sheet EQUATE - Amazon S3

Carcinogenicity Assessment of carcinogenicity: The product has not been tested. The statement has been derived from the properties of the individual components. The results of various animal studies gave no indication of a carcinogenic effect. Reproductive toxicity

  Sheet, Data, Safety, Studies, Carcinogenicity, Equate, Safety data sheet equate

NIOSH List of Antineoplastic and Other Hazardous Drugs in ...

2. Carcinogenicity in animal models, in the patient population, or both, as reported by the Interna-tional Agency for Research on Cancer (IARC) 3. Teratogenicity or fertility impairment in animal studies or in treated patients 4. Evidence of serious organ or other toxicity at low doses in animal models or treated patients.

  Drug, Other, Studies, Hazardous, Antineoplastic, Carcinogenicity, Of antineoplastic and other hazardous drugs

Safety Data Sheet Industrial Gear Oil EP 220

Safety Data Sheet Industrial Gear Oil EP 220 Version 1.02 Revision Date Print Date 100000006563 2/6 4. First aid measures Inhalation Move to fresh air in case of accidental inhalation of vapours. If breathing is irregular or stopped, administer artificial respiration.